Pegs Europe 2015 Protein & Antibody Engineering Summit

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LARGEST EUROPEAN PROTEIN & ANTIBODY ENGINEERING EVENT RETURNS TO LISBON
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26 June
• Network with 700 colleagues from 30+ countries
• See unpublished data from industry leaders
• Learn from 175 speakers and 125 poster presenters
• Record attendance each of the last three years
PLENARY KEYNOTES
Lorenz Mayr, Ph.D.,
AstraZeneca
Paul W.H.I. Parren, Ph.D.,
Genmab B.V.
Andreas Plückthun, Ph.D.,
University of Zurich
Tristan J. Vaughan, Ph.D.,
MedImmune Ltd.
Gregory A. Weiss, Ph.D.,
University of California, Irvine
PEGSProtein & Antibody Engineering Summit
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CONFERENCE-AT-A-GLANCE
SPONSORS
SHORT COURSES
Antibody Engineering Stream
Display of Antibodies
Bispecifics and Novel Biotherapeutics
Cancer Biotherapeutics
Biologics Development Stream
Optimisation & Development
Aggregates & Particles
Characterising Biotherapeutics
Impurities & Stability Stream
Purification Technologies
Formulation & Stability
Bioproduction Stream
Bioreactor Design & Engineering
Scaling-Up & Down
Protein Expression Stream
Engineering Expression Systems
Applying Expression Platforms
Scaling-Up & Down
SPONSOR & EXHIBIT OPPORTUNITIES
HOTEL & TRAVEL INFORMATION
REGISTRATION INFORMATION
FINAL AGENDA
2-6 NOVEMBER 2015 | EPIC SANA LISBOA HOTEL | LISBON, PORTUGAL
Seventh Annual

CORPORATE SUPPORT SPONSORS
PREMIER SPONSORS
Antibody
Engineering Stream
Biologics
Development Stream
Impurities &
Stability Stream
Bioproduction
Stream
Protein Expression
Stream
2 November:
Monday morning Pre-Conference Short Courses*
2-3 November: Monday
afternoon - Tuesday
Display of Antibodies Optimisation &
Development
Purification
Technologies
Purification
Technologies
Engineering
Expression Systems
4-5 November: Wednesday
- Thursday morning
Bispecifics & Novel
Products
Aggregates &
Particles
Aggregates &
Particles
Bioreactor Design &
Engineering
Applying Expression
Platforms
5 November:
Thursday evening Dinner Short Courses*
5-6 November: Thursday
afternoon - Friday
Cancer
Biotherapeutics
Characterising
Biotherapeutics
Formulation &
Stability
Scaling-Up & Down Scaling-Up & Down
“I was pleased to find so many scientists in the European industrial
sector who were willing to talk about their research in great detail.
It is a refreshing viewpoint when compared to similar conferences
held in the US.”
Kathleen H., Ph.D., Scientist, Cell and Systems Biology,
University of Toronto
“The best biologics technology meeting in Europe.”
Rakesh D., Ph.D., VP, R&D, MedImmune
“The presentations were
exceptional, covering
an extraordinary array of
antibody and antibody-
alternative technologies.
PEGS Europe is
unparalleled in both
scope and quality.”
Kevin R., Ph.D., Scientist,
Wellcome Trust Sanger Institute
“A great overview
highlighting almost all
aspects of antibody
development of the
current and next
generation. Almost a
perfect conference.”
Peter S., Ph.D., CSO, SuppreMol
*Separate registration required
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MORNING SHORT COURSES
MONDAY, 2 NOVEMBER, 9:00 – 12:30
SC1: Engineering of Bispecific Antibodies
Nicolas Fischer, Ph.D., Head, Research, Novimmune SA
Michela Silacci, Director, Discovery Research, Covagen AG, one of the Janssen
Pharmaceutical Companies of J&J
By attending this interactive workshop, you will learn about the various approaches
used for the engineering of bispecific antibodies and bispecific scaffold-based binding
proteins. Different technologies will be compared, and examples for applications
of bispecific antibodies in drug development will be presented with a focus on
candidates that are currently being evaluated in clinical trials. Opportunities and
challenges in the field of bispecific antibodies will be discussed.
SC2: Mutation and Selection Strategies for Multi-Parameter
Antibody Optimisation
William Finlay, Ph.D., Senior Director, Global BiotherapeuticTechnologies, Pfizer, Inc.
Orla Cunningham, Ph.D., Associate Director, Global BiotherapeuticTechnologies,
Pfizer, Inc.
In therapeutic antibody discovery, few lead molecules meet all of the demanding
standards required to become a drug. As a result, most antibodies will require some
form of engineering and optimisation.This course aims to help attendees navigate the
complex workflows and technological options required to be successful.
SC3: CHO Cell Engineering
Anton Bauer, Ph.D., COO,The Antibody Lab
Simon Fischer, Ph.D., Research Scientist, Institute of Applied Biotechnology,
University of Applied Sciences Biberach
Zhiwei Song, Ph.D., Principal Scientist, Lead PI for GlycoSing Programme,
BioprocessingTechnology Institute, A*STAR
Recombinant protein therapeutics have proven their worth as invaluable
pharmaceuticals. Chinese hamster ovary (CHO) cells are the primary choice by
industry for the production of these proteins, owing to their capacity for correct
folding, assembly and posttranslational modification.The growing demand for
therapeutic proteins necessitates the development of new technologies for high
quality and productivity in CHO expression systems.This course explores CHO cell
engineering strategies to improve and select for the highest producers.
SC4: Protein Purification Strategies: Dealing with Proteins that Are
Prone to Aggregate
Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Centre for
Applied Structural Biology,The Hebrew University of Jerusalem
This course will provide a comprehensive and detailed outline of hands-on issues
for purifying proteins. We will first address general considerations about the protein
we want to produce, including issues of activity, solubility, homogeneity, purity, and
proper oligomeric conformation. Aggregation is one of the main obstacles in protein
production, so we will look at how to monitor for aggregation and comprehend its
mechanism. We will also discuss how to check for the optimal solubility conditions at
the expression level, and our comprehensive approach for optimizing solubility during
purification. We will also discuss expression screening methodology, environmental
factors to consider during purification, families of additives, and screening for
additives. Lastly, we will address ways to avoid aggregation, as well as setting up
protein concentration and storage.
DINNER SHORT COURSES
THURSDAY, 5 NOVEMBER, 17:30 – 20:30
SC6:Troubleshooting and Engineering of Antibody Constructs
Jonas Schaefer, Ph.D., Head, High-Throughput Binder Selection Facility, Biochemistry,
Julia Neugebauer, Ph.D., Associate Director, Leader Discovery Programs, MorphoSys AG
Recombinant antibodies vary widely in their biophysical characteristics, from stable
monomers to metastable aggregation-prone oligomers. In particular, antibody variable
domains differ in their intrinsic thermodynamic stability and may require labour-
intensive engineering. It is therefore essential to implement antibody engineering
strategies in screening and initial characterisation project phases in order to avoid
time and cost consuming optimisation strategies in later development. In addition, it
is critical to understand how the poor stability of individual variable domains not only
limits the biophysical properties of small fragments, but also affects the production
yield, stability and homogeneity of full-length IgGs containing these domains.
SC7: Immunotherapy in the 21st Century: More Specificity, More
Potency, BetterTargeting
Christian Klein, Ph.D., Head, Oncology Programs, Roche Pharmaceutical Research &
Early Development, Roche Innovation Center Zurich
Jos Melenhorst, Ph.D., Director, Product Development & Correlative Sciences Labs,
University of Pennsylvania
Part One of this course will give an overview of validated and emerging targets
for cancer immunotherapy and mechanisms of action of antibody-based cancer
immunotherapy. It will cover ADCC-enhanced antibodies,T cell bispecific antibodies,
CAR-T; and checkpoint inhibitory and agonistic antibodies. PartTwo will discuss
current cellular therapies of cancer, and how the synergy of basic biology, translational
research, and biotechnology have allowed us to better target tumour cells, enhance
the potency, and look for new ways to collaborate across the immune system.
SC8:The Challenge of Protein Aggregation and Formation of Sub
Visible Particles in the Development of Biopharmaceuticals
Tudor Arvinte, Ph.D., Chairman & CEO,Therapeomic, Inc.
Attendees of this 3-hour short course will gain a critical overview of the complexity
and diversity of the aggregation and sub-visible particles of peptide and protein
biopharmaceuticals and on strategies to overcome these issues. The course will
cover different aggregation mechanisms; available techniques for detection of
aggregation and impurities and how these methods can be applied; strategies for
developing stable peptide drug formulations using HT analysis and HT formulation
platforms; as well as aggregation of biopharmaceuticals in human plasma – a new
development and research field.
SC9: AdvancedTechniques for Characterisation of Protein Aggregates,
Particulates and Contaminants
Matthew Brown, Ph.D., Life Science Specialist, Malvern Instruments
Amber Fradkin, Ph.D., Associate Director, R&D, KBI Biopharma
Stacy Kenyon, Ph.D., Scientist, Bioscience Development Initiative, Malvern Instruments
Understanding the complex process of protein aggregation is key to the
implementation of QbD approaches during biotherapeutic development or
deviation resolution of legacy products. Such in-depth understanding relies on the
implementation of advanced characterization technologies. Using these advanced
techniques, the biopharmaceutical industry is now offered detailed insights into
protein behaviour, allowing evaluation of product stability and process impact.This
course will cover some of the latest technologies for advanced characterization
of protein therapeutics, together with case studies from industry, on how such
approaches can be implemented for product development and understanding.
SHORT COURSES*
Make the Most ofYourTime in Lisbon! Maximize your educational
and networking opportunities by adding a short course.
*Separate registration required for short courses
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ANTIBODY ENGINEERING STREAM
2-3 November 2015 | SECOND ANNUAL
Empowering Novel Biologics
Recommended Short Course*
(*Separate registration required. Please see Page 3 for more details.)
MONDAY, 2 NOVEMBER
12:00 Conference Registration
COMBINED KEYNOTE SESSION
13:40 PEGS EuropeTeam Welcome
13:45 Chairperson’s Opening Remarks
Darrell Sleep, Director, Novozymes Biopharma R&D
13:50 Protein Engineering for New Modes
of Actions and NewTargets
Andreas G. Plückthun, Ph.D., Professor & Director, Biochemistry,
Using different display technologies and structure-based engineering,
the possibilities of hitting extra- and intracellular targets will be
discussed, with an emphasis on extending the modes of action previously
possible. The lecture will emphasise the need for interdisciplinary approaches.
14:30Targeting Ion Channels
Tristan J. Vaughan, Ph.D., Senior Director, Antibody Discovery &
Protein Engineering, MedImmune Ltd.
Ion channels are complex integral membrane proteins that form a
pore through which ions selectively pass down an electrochemical
gradient. They are prominent components of the nervous system where
they can mediate transduction across synapses. Hence, certain channels
represent good drug targets, especially for alleviating pain. Approaches will be
described to target such ion channels with antibody-based drugs and a case
study presented.
15:10 Current and FutureTrends in AntibodyTherapeutics
Paul W.H.I. Parren, Ph.D., Senior Vice President & Scientific Director,
Preclinical Development & Research, Genmab
Targeted treatment using antibody therapeutics has proved
successful in the development of meaningful treatments in diverse
therapeutic areas. However, despite strong advances, many patients still fail
to respond or become resistant to targeted treatment and novel innovative
approaches to improve therapy are therefore required. Genetic and chemical
engineering of antibodies, fueled by recent molecular insights, is providing
important opportunities for the development of more potent antibody
therapeutics. Examples from Genmab’s portfolio will be provided.
15:50 Refreshment Break in the Exhibit Hall with Poster Viewing
EUKARYOTIC DISPLAY
16:30 Chairperson’s Remarks
John McCafferty, Ph.D., Co-Founder, Director and CEO, IONTAS Ltd.
16:35Yeast-Based Platform to Select Rare Specificities and High
Affinity Antibodies
Trevor A. Wattam, Ph.D., Manager, Biopharm Discovery Group, GlaxoSmithKline
This talk will provide an overview of GSK experiences with Adimab’s yeast-based
platform. It will provide an overview of the lead discovery processes. In addition a
couple of case studies will be presented demonstrating the power of employing
FACS-based selection to identify rare specificities and select high affinity antibodies.
17:05 Construction and Use of Large Antibody Libraries in
Mammalian Cells
John McCafferty, Ph.D., Co-Founder, Director and CEO, IONTAS Ltd.
Using nuclease-directed integration of antibody genes we have constructed large
libraries in mammalian cells containing a single antibody gene/cell. This allows
surface display of antibodies, including IgG formatted antibodies, on the cell surface.
This will permit the screening of millions of clones by flow sorting and provide
information on both expression level and the extent of binding within the cell types
used for antibody production.
17:35 Antibody Library Display on a Mammalian Sponsored by
Virus: Combining the Advantages of Panning and Cell
Sorting in OneTechnology
Ernest S. Smith, Ph.D., Senior Vice President, Research & Chief Scientific Officer,
Vaccinex, Inc.
We have developed an antibody discovery platform that enables efficient
mammalian cell based expression of a library of human antibodies in full length IgG
format on the surface of a mammalian virus. Upon infection of mammalian cells the
antibody is not only incorporated into newly produced virus, it is also displayed on
the surface of the host cell. This technology allows us to combine the advantages of
virus panning and cell sorting into one technology.
18:05 Welcome Reception in the Exhibit Hall with Poster Viewing
19:05 End of Day One
TUESDAY, 3 NOVEMBER
07:45 Registration and Morning Coffee
NEWTECHNOLOGIES
Kerry Chester, Ph.D., Professor, Molecular Medicine, University College London
Cancer Institute
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08:40 DNA-Encoded Chemical Libraries for the Isolation of High-
Affinity Binding Ligands: An Alternative to Antibodies
Dario Neri, Ph.D., Professor, Chemistry and Applied Biosciences, Swiss Federal
Institute of Technology (ETH Zürich)
The tagging of chemical compounds with DNA fragments, serving as amplifiable
identification barcodes, allows the construction and screening of libraries of
unprecedented size. The isolation of small organic ligands from DNA-encoded
chemical libraries facilitates drug discovery applications.
09:10 Deep Microfluidic Screening for Discovery of Rare Antibodies
with Optimal Properties
William S. Somers, Ph.D., Vice President, Global Biotherapeutic Technologies, Pfizer
We are in a collaboration with HiFi Bio to establish a next generation microfluidic
platform for antibody discovery that is allowing us to screen very large numbers of
B-cells from humans and immunized animals for molecules that possess properties
of interest. The massive throughput of the instrument and information rich assays
allow us to identify rare antibodies that have both the biological activity of interest
and favorable manufacturing properties.
09:40 PROBLEM SOLVING ROUNDTABLE DISCUSSIONS
Table 1:The Role of in vivo Molecular Imaging in the Development
of Immunotherapy
Moderator: Adam Badar, Ph.D., Head, Preclinical Nuclear Medicine, Centre for
Advanced Biomedical Imaging (CABI), University College London
Table 2: Comparison ofTechnologies: Hybridoma, Phage,
Transgenics and the Kitchen Sink
Moderator: Jacob Glanville, CSO, Distributed Bio LLC
Table 3: Next-Generation Sequencing of Phage Display Panning
Output Pools to Guide Antibody Lead Selection
Moderator: Stefan Ewert, Ph.D., Senior Investigator, NIBR Biologics Center,
Novartis Pharma AG
10:40 Coffee Break in the Exhibit Hall with Poster Viewing
USING DISPLAY FOR IMMUNOTHERAPY APPLICATIONS
Ernest S. Smith, Ph.D., Senior Vice President, Research & Chief Scientific Officer,
Vaccinex, Inc.
11:20 EngineeredT Cell Receptors asTools for the Study of Peptide–
MHC Interactions
Geir Åge Løset, Ph.D., Researcher, Centre for Immune Regulation and Department
of Biosciences, University of Oslo; CSO, Nextera AS
The use of phage display as tool to evolve cloned T cell receptors represents an
attractive avenue to generate reagents for mechanistic studies of native pMHC
engagement. We have systematically looked into domain format variants and phage
display engineering to obtain such functional soluble T cell receptors allowing for a
deeper disease mechanism elucidation within autoimmunity. In parallel, we have
also developed alternative pMHC-targeting units by phage display.
11:50 Multiscale, Multimodal in vivo Imaging of CART CellTherapies
Adam Badar, Ph.D., Head, Preclinical Nuclear Medicine, Centre for Advanced
Biomedical Imaging (CABI), University College London
Adoptive immunotherapy using chimeric antigen receptor (CAR) engineered T cells
has shown promising results in treating various cancer types. In vivo imaging plays
a key role in the development of CAR T cell therapies, allowing us to study their
homing, engraftment, expansion, persistence and demise longitudinally and non-
invasively in animal and man. This talk will provide an overview of current state-of-
the-art multiscale and multimodality imaging technologies available.
12:20 Screening and Charactersation of Biologics Sponsored by
using a High Sensitivity Plate-based Laser
Scanning Cytometer
Paul Wylie, Ph.D., Head, Instrumentation Applications Group, TTP LabTech Limited
The mirrorball fluorescence cytometer is applicable to many stages within biologics
discovery from screening to identify hits to binding characterisation and monitoring
phenotypic responses. Streamlined no wash cell or bead-based assays provide
process efficiencies over standard Flow or ELISA formats, enabling you to do more
with precious samples and time.
12:35 Sponsored Presentation (Opportunity Available)
12:50 Luncheon Presentation (Sponsorship Opportunity Available) or
Enjoy Lunch onYour Own
13:20 Session Break
14:00 Dessert Break in the Exhibit Hall with Poster Viewing
ANTIBODY GENERATION
Gregory A. Weiss, Ph.D., Professor of Chemistry, Molecular Biology and
Biochemistry, University of California, Irvine
14:35 Next-Generation Sequencing of Phage Display Panning Output
Pools to Guide Antibody Lead Selection
Stefan Ewert, Ph.D., Senior Investigator, NIBR Biologics Center, Novartis Pharma AG
With the availability of bench-top personal sequencers it is now possible to apply
Next Generation Sequencing (NGS) of Phage Display panning output pools during the
antibody discovery process. Starting with a polyclonal 1.0E+06 Phage Display output
pool after 3 panning cycles followed by adapted panning conditions and NGS analysis,
we have been able to predict cross-reactivity profiles and biophysical properties like
melting temperature of antibody candidates. Ultimately, we aim to replace classical
screening methods and rely solely on adapted panning strategies followed by NGS to
identify antibody leads out of the complete Phage Display output pool.
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15:05 Call of the Wild: A New Generation of Antibody Discovery from
Natural Sources
Jacob Glanville, CSO, Distributed Bio LLC
The integration of new immunological insights, phage indexing technologies,
and seven years NGS algorithm development has armed new design principles
to harvest antibodies from natural repertoires. First, we review modeled insights
gained from attempting to mimic nature by synthetic methods, with applications in
in vitro SHM replacement and novel humanization technology. Next, we present a
computationally-guided SuperHuman library built from natural sources. Finally, we
describe a Survivor library generated from the blood of an army of cancer survivors.
15:35 Phenotypic Screening for Novel AntibodyTargets in the
Tumour Microenvironment
Ralph R. Minter, Ph.D., Fellow, Antibody Discovery and Protein Engineering,
MedImmune Ltd.
There is growing interest in finding and validating novel targets in the tumour
microenvironment, especially in the burgeoning field of immunotherapy. We have
been using phage display and phenotypic screening of antibodies to identify
and validate novel targets both on cancer cells and immune cells which infiltrate
tumours. Examples will be given to demonstrate the advantages of phenotypic
screening for the identification of targets and drug leads in this context.
16:05 Combining the Benefits of Immunized Libraries, Sponsored by
in vitro Selections and Computational Design for
Antibody Discovery
Vera Molkenthin, Ph.D., Chief Scientist, AbCheck s.r.o
Rabbits are known to produce high affinity and diverse antibodies even against
difficult targets. A library-based method allows the humanization of the complete
VH/VL sequence repertoire of an immunized rabbit in one batch and offers a new
approach to antibody discovery. The libraries are computationally designed for
optimal developability properties, excluding T-cell epitopes and biochemical liabilities.
Special strategies allow the selection of antibodies with slow dissociation rates,
species cross reactivity and high thermal stabilities.
16:35 Refreshment Break in the Exhibit Hall
with Poster Viewing
TARGETING DIFFICULT ANTIGENS WITH
DISPLAYTECHNOLOGIES
Claire Dobson, Ph.D., Associate Director, Antibody Discovery & Protein Engineering,
MedImmune Ltd.
17:15 Dissecting and Engineering Phage-Displayed Membrane Proteins
Membrane proteins (MPs) control the cell’s communications, sensing and
responses to extracellular events. Yet MPs most remain off-limits to conventional
protein engineering. The Weiss laboratory has reported a new type of bacteriophage
allowing display and mutagenesis of this important class of proteins. The approach
opens new frontiers to dissect and tailor binding by MPs and their binding partners.
Several examples illustrating the power of the approach will be presented.
17:45 Computer-Guided Design of Antibodies Combined with Display
Technologies to Identify Antibodies to DifficultTargets
Yanay Ofran, Ph.D., Founder, Biolojic Design Ltd.
Display technologies select for binding, not for activity. But the functional effect
of an antibody is determined by the mode of binding, not only by the affinity. This
talk will present a data-driven computational approach for designing of libraries
that can yield binders with a preselected mode of binding. It has shown success in
designing antibodies against difficult targets as well as bi-specific antibodies.
18:15Targeted Modulation of hERG Channel Activity with scFv
Antibody Fragments
Carol A. Harley, Ph.D., Research Scientist, Structural Biochemistry, IBMC- Instituto
de Biologia Molecular e Celular
The KCNH voltage-dependent potassium channels have key roles in diseases such
as cardiac LQT2 syndrome, schizophrenia and cancer. The intracellular domains of
the hERG ion channel are important for modulating it´s activation properties. We
have isolated and identified novel scFv antibodies that target specific regions within
the N-terminal cytoplasmic domain of the hERG channel which modulate channel
kinetics. This opens up a novel mode of ion channel modulation.
18:45 End of Display of Antibodies
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4-5 November 2015 | SEVENTH ANNUAL
Platform Development, Structure/Function Relationship, and Target and Target Pair Selection
Recommended Short Courses*
SC6:Troubleshooting and Engineering of Antibody Constructs
(*Separate registration required. Please see page 3 for more details.)
WEDNESDAY, 4 NOVEMBER
BISPECIFIC PLATFORMS
Jonas V. Schaefer, Ph.D., Head, High-Throughput Binder Selection Facility,
Biochemistry, University of Zurich
»»KEYNOTE PRESENTATION
08:35 Re-Envisioning “Classical” CancerTherapy through the Lens
of the Immune System to Develop Optimal Combination Immune
Therapies
Israel Lowy, M.D., Ph.D., Vice-President, Clinical Sciences; Head,
Translational Science and Oncology, Regeneron Pharmaceuticals, Inc.
Regeneron is conducting new clinical trials with REGN1979, an
anti-CD20xCD3 bispecific antibody, to treat CD20+ NHL or CLL, and
REGN2810, an anti-PD-1 mAb for multiple tumor types. Each is being developed
as an immunologic foundation for therapeutic regimens capable of eliciting
durable responses. Further augmentation of anti-tumor activity by combination
with classical agents will not rely on standard of care dosing, but instead seek to
optimize their immune enhancing effects.
09:20 Seamless Bispecific Antibody Discovery and Development
Using the Duobody Platform: An EGFR x cMet Case Study
Janine Schuurman, Ph.D., Vice President, Research, Genmab B.V.
The DuoBody platform represents a novel and elegant post-production technology
for the generation of stable bispecific antibodies. General strategies, and
considerations, for bispecific antibody discovery will be discussed. The suitability of
the DuoBody platform for bispecific discovery approaches, showing the importance
of doing this in the final format - illustrated by surprising findings, will be shown in a
case study selecting a lead cMetxEGFR bispecific antibody.
09:50 Generation, Novel Insights and Clinical Update of Factor VIII
Mimetic Bispecific Anti-Factor IXa/Factor X IgG Antibody
Tomoyuki Igawa, Ph.D., Group Manager, Discovery Research, Chugai Pharmaceutical
ACE910 is a humanised anti-factors IXa and X bispecific IgG that places two factors
into proximity and mimics factor VIII function for treating hemophilia A overcoming
the issues of current treatment. Generation of ACE910, novel insights in unique
contribution of non-antigen contacting region on the activity, and interim data of the
Phase I and extension study combined will be presented.
10:20 Engineering Next-Generation Biotherapeutics:
Developability & Manufacturability
Maria Wendt, Ph.D., Head, Science, Biologics, Genedata
Next-generation biotherapeutics, specifically bi- and multi-specifics, alternative
scaffolds, and ADCs, provide significant advantages over traditional IgG-based
molecules. However, as highly engineered molecules they pose new design,
cloning, expression, purification, and analytics challenges. Our workflow platform
automates the engineering, production, and testing of large panels of these candidate
therapeutic molecules. We demonstrate the platform’s capability to explore the huge
combinatorial space of novel molecule-specific designs, its high-throughput capability,
and its built-in tools for developability and manufacturability assessments.
11:30 Development of Dual-Targeting Anti-CD47 Bispecific Antibodies
Krzysztof Masternak, Ph.D., Head, Biology, Research, Novimmune SA
Dual-targeting antibodies (kλ-bodies) allow selective CD47 neutralisation in cancer
cells expressing a particular cell surface antigen (in this case, CD19 or mesothelin),
which is important, given that CD47 is ubiquitously expressed – including in
RBC, platelets and other blood cells. I will present recent in vivo and in vitro data
showing that our dual-targeting anti-CD47 bispecific antibodies have superior
pharmacological properties in the clinic (PK, toxicity, a broad therapeutic window) as
compared to monoclonal anti-CD47 antibodies.
12:00 Novel Bispecific Antibodies forTreatment of Chronic Hepatitis B
Virus Infection and AssociatedTumours
Felix Bohne, Ph.D., Principal Investigator, Institute of Virology, Helmholtz Centre Munich
Chronic hepatitis B is characterised by exhausted effector cells incapable of
eradicating the virus. To circumvent this limitation, HBV-specific retargeting of
immune effector cells using bispecific monoclonal antibody (BiMab) constructs is
a promising therapeutic approach. ScFv-driven tetravalent BiMab showed excellent
PBMC-retargeting efficacy and in vitro killing of HBV-transgenic and infected
hepatocytes. Translation into a relevant humanised mouse model yielded first proof-
of-principle results targeting HBV-positive tumours.
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12:30 Creating Focused Libraries for Protein Sponsored by
Engineering
Nels Thorsteinson, Scientific Services Manager, Biologics,
Chemical Computing Group
Protein engineering plays a pivotal role in modulating the function, activity and
physical properties of biologics. Representative strategies employed in protein
engineering include directed evolution and rational protein design. Although
both approaches are effective at identifying and optimizing protein therapeutic
candidates, efficient search and evaluation of an excessively large sequence
design space becomes challenging and requires multiple experimental rounds to
reasonably assess the sequence space. Here we have developed a computational
approach which predicts mutation probabilities for given residue sites in specified
sequences. In assessing the probabilities at given residue sites, the sequence
search space can be efficiently sampled to design and produce focused
mutant libraries.

13:00 Luncheon Presentation
(Sponsorship Opportunity Available) or Lunch onYour Own
13:30 Session Break
TARGET SELECTION AND SPECIFICITY
Ulrich Brinkmann, Ph.D., Expert Scientist, Roche Pharma Research & Early
Development, Roche Innovation Center, Penzberg
14:05 Improved Binder Specificity by Using Structural Epitope
Recognition
Jonas V. Schaefer, Ph.D., Head, High-Throughput Binder Selection Facility,
Biochemistry, University of Zurich
Specificity is a major challenge in the usage of affinity reagents for both therapeutic
and diagnostic applications. Using our binder selection pipeline and novel ways of
target presentation, we were able to tackle this issue. I will present data on ongoing
projects targeting viral infections and neurodegenerative diseases, two fields of
applications where target conformation is of critical importance.
14:35The Use of Serum Compatibility to Select Bispecific Antibodies
Mark Chiu, Ph.D., Associate Director, Multispecific Biologics Engineering, Biologics
Research, Janssen Research & Development LLC
Bispecific antibody (bsAb) engineering can change protein symmetry and
consequently molecular properties. Characterisations of bsAb in the presence of
sera can assess potential self-interaction and interactions between the molecule
and serum proteins which can affect PK, efficacy, aggregation, and immunogenicity.
We present in vitro biophysical characterisations using spectroscopy and
chromatography that can be used in developability to support lead selection.
15:05 HighThroughput Approach to Select SynergisticTarget Pairs
and Bispecific Antibodies
Jijie Gu, Ph.D., Senior Principal Research Scientist, Global Biologics, AbbVie
Bioresearch Center
Bispecific antibodies have emerged as one of the important approaches for next
generation antibody-based therapeutics. One of the key challenges the bispecific
antibody field is facing is how to identify target pairs and bispecific molecules with
novel biology. This presentation will discuss a high-throughput approach to identify
target pairs and bispecific antibodies with potential synergistic effect.
BISPECIFICS FOR IMMUNO-ONCOLOGY
16:15 Bispecific Anticalin Fusion Proteins for LocalisedTargeting of
Immune Cells for Application in Immuno-Oncology
Christine Rothe, Ph.D., Vice President, Discovery & Alliance Management, Pieris
Pharmaceuticals, Inc.
Anticalin® proteins are derived from human lipocalins and are about 18 kDa in size.
We have generated different bispecific constructs by fusing distinct Anticalin proteins
to each other or by fusing Anticalin proteins to antibodies or Fc-domains.These
constructs simultaneously bind a tumour and aT cell target and may be able to better
controlT cell activation in the tumour mircoenvironment. Binding properties, stability
and in vitro functionality of bispecific Anticalin fusion proteins are presented.
16:45The Dual-Dual-Targeting Concept - Enhancing Natural Killer
Cell-Mediated Lysis of Lymphoma Cells by CombiningTherapeutic
Antibodies with Bispecific Immunoligands Engaging NKG2D or NKp30
Matthias Peipp, Ph.D., Group Leader, Stem Cell Transplantation and Immunotherapy,
Christian-Albrechts-University of Kiel
Novel bispecific immunoligands were compared for their abilities to boost ADCC in
an attempt to design an effective antibody combination strategy. Co-targeting and
activating NK cell receptors may represent a promising approach for enhancing the
efficacy of therapeutic antibodies. A ‘dual-dual-targeting’ concept by co-targeting
two tumour antigens and concomitant engagement of two different activating NK
cell receptors is proposed.
Table 13: Comparing Bispecific Antibody Platforms: Key Features
Moderator: Janine Schuurman, Ph.D., Vice President, Research, Genmab B.V.
Table 14: Benefits of Bispecifics over CombinationTreatments
Moderators: Krzysztof Masternak, Ph.D., Head, Biology, Research, Novimmune SA
Sarah Batey, Ph.D., Principal Scientist, Tumour Biology and Protein Science,
F-star Biotechnology Ltd
Table 15: Improved Methods for Binder Screening and Validation
Moderator: Jonas V. Schaefer, Ph.D., Head, High-Throughput Binder Selection
Facility, Biochemistry, University of Zurich
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18:15 Networking Reception in the Exhibit Hall with Poster Viewing
19:15 End of Day
THURSDAY, 5 NOVEMBER
08:00 Morning Coffee
NOVEL APPROACHES FOR ONCOLOGY
Janine Schuurman, Ph.D., Vice President, Research, Genmab B.V.
08:35 Exploiting the Versatility of Alphabodies toTarget the Intrinsic
Pro-Survival Protein MCL-1
Yvonne McGrath, Ph.D., CSO, Complix NV
Alphabodies are stable proteins where 70% of residues are amenable to
modification by design or library selection. These features have been exploited in
the design of Alphabodies which target the intracellular intrinsic pro-survival protein
MCL-1. These Alphabodies have been shown to bind specifically to MCL-1 with high
affinity and crystal structures obtained. Efficient uptake of the Alphabodies into cells
and cell killing of MCL-1 dependent tumour cells has also been demonstrated.
09:05 An Engineered Fc FragmentTargeting HER2 Induces Profound
Anti-Tumour Effects through Apoptosis
Sarah Batey, Ph.D., Principal Scientist, Tumour Biology and Protein Science, F-star
Biotechnology Ltd.
FS102 is a HER2 specific Fcab™ (Fc fragment with antigen binding) that induces
profound HER2 degradation and potent cell apoptosis in tumour cells expressing
high levels of the receptor. The efficacy of FS102 in patient-derived xenograft
(PDX) models correlates strongly with clinically relevant HER2 biomarkers. We
hypothesise that FS102 depletes HER2 which commits the HER2-addicted
tumour cells to apoptosis through oncogenic shock. FS102 is currently in Phase I
clinical trials.
09:35 Hapten-Directed Spontaneous Disulfide Shuffling:A Universal
Technology for Site-Directed Covalent Coupling of Payloads toAntibodies
Ulrich Brinkmann, Ph.D., Expert Scientist, Roche Pharma Research & Early
Development, Roche Innovation Center, Penzberg
Hapten-binding antibodies with accessible cysteine in proximity to the binding
pocket were designed to covalently attach payloads to the antibody. Payloads
carrying thiols become positioned on the antibody and linked by spontaneous
redox shuffling. Attachment works with different haptens, antibodies and payloads.
Applications include modulation of pharmacokinetics of small compounds as well as
payload linkage to targeting vehicles in a reduction-releasable manner.
10:05 Applications of Genetically Engineered Sponsored by
Single Domain Antibodies
Marshall Dunlop, Group Leader, Recombinant Antibodies R&D,
Randox
BISPECIFICS FOR ONCOLOGY
11:15 Anti-CD20/CD3T Cell Dependent Bispecific Antibody (TDB) as
PotentialTherapy for B Cell Malignancies
Laura Sun, Ph.D., Senior Research Associate/Project Lead, Translational Oncology,
Genentech, Inc.
The preclinical development of a B cell targeting anti-CD20/CD3 T-cell dependent
bispecific antibody (CD20-TDB) will be described. CD20-TDB is highly active in
killing B cells in vitro and in vivo as demonstrated in multiple murine models. In
cynomolgus monkeys, CD20-TDB potently depletes B cells in peripheral blood and
lymphoid tissues while demonstrating PK properties similar to those of conventional
monoclonal antibodies.
11:45 Impact of Bispecific and Multi-Specific Molecule Structure on
Safety and Efficacy
Tariq Ghayur, Ph.D., Distinguished Research Fellow, DVD-Ig and Novel Biologics,
Global Biologics, AbbVie, Inc.
Bi- and multi-specific formats differ in their target binding domain placement,
distance and valency. These differences may be critical when targeting cell surface
receptors. Therefore, designing the right format to match target and / or target pair
biology may be important for selecting therapeutic candidates with desired safety,
efficacy and PK profiles.
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5-6 November 2015 | THIRD ANNUAL
Immunotherapies, ADCs, and Combination Approaches
Potency; BetterTargeting
12:30 Registration
ADOPTIVET CELLTHERAPY
Rakesh Dixit, Ph.D., Vice President, Safety Assessment, MedImmune (A member of
AstraZeneca)
13:35 CancerTherapy byT Cell-Engaging Antibody Constructs
Tobias Raum, Ph.D., Scientific Director, Lead Generation, AMGEN
Research (Munich) GmbH
Bispecific T cell-engaging (BiTE®
) antibody constructs can transiently link
tumour cells with otherwise inactive cytotoxic T cells for induction of
potent redirected lysis of attached tumour cells. One example is blinatumomab
(AMG 103), a CD19/-CD3-bispecific BiTE®
antibody construct for the treatment of
acute lymphocytic leukaemia (ALL) and non-Hodgkin’s lymphoma (NHL), which
has been filed in the EU for treatment of relapsed/refractory ALL, and approved
in the US by the FDA in December 2014.
14:20 Bispecific Antibodies for RedirectingT-Cell Killing: Ag and Ab
Factors Affecting the Killing Potency
Diego Ellerman, Ph.D., Senior Research Associate, Protein Chemistry, Genentech, Inc.
T cell redirected cell killing is an expanding therapeutic approach in oncology.
Bispecific antibodies targeting both the T cell receptor and a tumour-specific antigen
are being developed for this approach. This presentation will explore the influence
of antigen density, antibody affinity and epitope distance to the membrane on the
antibody potency using Her 2 and other antigen models.
14:50 Cancer Biotherapeutics - Affimers: A Novel Sponsored by
Scaffold for Biotherapeutics
Amrik Basran, Ph.D., CSO, Therapeutics, Avacta Lifesciences
Affimers are a new protein scaffold with great potential for the generation of
biotherapeutics. Based on the protease inhibitor Stefin A, large diverse libraries
have been created by engineering in peptide loops into the scaffold backbone.
Using phage display, we have identified competitive binders to a ranage of targets,
including the immune check point, PD-L1. We have shown that the scaffold is
amenable to being engineered with a range of half-life extension technologies,
giving “IgG like” PK.
with Poster Viewing
16:05 A NovelT Cell-Engaging Bispecific Format with Full-Length
Antibody Properties - Applications in Cancer Immunotherapy
Seung Y. Chu, Ph.D., Associate Director, Cell Biology, Xencor, Inc.
Bispecific antibody-mediated coengagement of T cells with tumour antigens is
now a proven therapeutic strategy, but inferior stability, production and half-life
have hindered clinical development. We have engineered modular Fc-containing
bispecifics linking a portable CD3 with full-length antibodies against many tumour
antigens. I will present development case studies of several bispecifics, showing
superior pharmacology and half-life in monkeys plus efficient manufacturing.
16:35 Immtacs: Bi-SpecificTCR-Based Reagents forTargeted
Cancer Immunotherapy
Joseph Dukes, Ph.D., Head, Preclinical Biology, Cell Biology, Immunocore Ltd.
ImmTACs are a novel class of soluble bi-specific reagents that exploit the natural antigen
recognition pathway mediated by theT cell receptor (TCR), fused to a powerful effector
function (anti-CD3) to redirectT-cell activity against tumour cells.This presentation will
introduce the ImmTAC platform and the latest clinical data from our lead candidate,
IMCgp100, currently in a Phase I/IIa trial for the treatment of malignant melanoma.
17:05 End of Day
17:00 – 17:30 Dinner Short Course Registration*
Potency; BetterTargeting
(*Separate Registration Required. Please see page 3 for more details)
FRIDAY, 6 NOVEMBER
IMMUNE CHECKPOINTS
Stephen Beers, Ph.D., Associate Professor, Cancer Sciences Unit, Faculty of
Medicine, University of Southampton
08:05 Combinations of Check-Point Inhibitors with the First-in-Class
Therapeutic NK-Cell BindingTandAb AFM13 (CD30/CD16A)
Martin Treder, Ph.D., CSO, Affimed
The tetravalent bispecific TandAb AFM13 recruits and activates NK cells by specific
binding to CD16A and mediates potent lysis of CD30+ tumour cells. Given
promising clinical safety and efficacy data and the mechanistic involvement of
immune effector cells, potential synergy with various check point inhibitors was
investigated pre-clinically and will be presented.
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08:35 Innovations in Cancer Biotherapeutics: Immune Checkpoint
Antagonists, Agonists and Combinations
Rakesh Dixit, Ph.D., Vice President, Safety Assessment, MedImmune (A member of
AstraZeneca)
The approval of one CTLA-4 and two PD-1 immune checkpoint antagonistic cancer
biotherapeutics has rejuvenated the innovations in discovering and developing new
immunotherapies that could increase responses and delay cancer associated deaths.
The presentation will discuss the innovations in new immune checkpoint antagonists
and agonists that show great promise in revolutionising cancer treatments.
09:05T-DM1 Reinstates Anti-Tumour Immunity in HER2-Positive
Breast Cancer: Synergies with α-CTLA-4 and α-PD-1
Philipp Müller, Ph.D., Project Leader, Biomedicine, University Hospital of Basel
ADCs such as the HER2-directed antibody-maytansinoid conjugate T-DM1 have
emerged as one of the most powerful therapeutic formats for cancer therapy. In
this presentation I will demonstrate that T-DM1 is particularly effective in eliciting
anti-tumour immune responses in breast cancer patients and a HER2-expressing,
syngeneic and orthotopic tumour model. Our data reveal a novel immunological
mechanism of action for T-DM1 and provide a strong rationale for clinical
combinations with immunotherapies.
Table 22: Enhancement of Potency for RedirectedT Cell Killing
Moderator: Seung Y. Chu, Ph.D., Associate Director, Cell Biology, Xencor, Inc.
Table 23: Safety Risks of Immunotherapy Combinations: Risk
Mitigation Strategies
Moderator: Rakesh Dixit, Ph.D., Vice President, R&D, Safety Assessment,
MedImmune, Inc.
Table 24:Technologies for the Construction of Next-Generation ADCs
Moderator: Vijay Chudasama, Ph.D., Lecturer, Chemistry, University College London
10:35 Coffee Break with Poster Viewing
IMMUNOMODULATORY MECHANISMS / CHIMERIC
ANTIGEN RECEPTORTHERAPY
11:00 Understanding How Isotype Determines the Mechanism of
Action of Immunomodulatory Antibodies in theTreatment of Cancer
Stephen Beers, Ph.D., Associate Professor, Cancer Sciences Unit, Faculty of
Medicine, University of Southampton
Clinical results with checkpoint-blocking mAb have revived the belief that
the immune system holds the key to controlling cancer. Here we show that
immunostimulatory mAb can employ multiple mechanisms in tumours, and that the
mechanism used depends on mAb isotype and FcγR availability. These data have
broad implications for developing immunomodulatory mAb; illustrating the necessity
to determine all potential mechanisms of action to maximise activity.
11:30 A Novel IgG-BasedT Cell Bispecifics Platform
Christian Klein, Ph.D., Head, Oncology Programs, Roche Pharmaceutical Research &
Early Development, Roche Innovation Center Zurich
The presentation will introduce a novel IgG-based T cell bispecific (TCB) antibody
platform enabled by the CrossMAb technology. Engineering, design and advantages
as compared to existing T cell bispecifics platforms will be discussed. As a case
study the preclinical properties of the CEA-CD3 TCB (RG7802) that is currently in
Phase 1 clinical trials will be discussed.
ADC / IMMUNE CHECKPOINT COMBINATION
12:00 Chimeric Antigen Receptor Re-DirectedT CellTherapy:
Biomarkers Lead the Way
J. Joseph (Jos) Melenhorst, Ph.D., Director, Product Development & Correlative
Sciences, Center for Cellular Immunotherapies, University of Pennsylvania
T cells equipped with chimeric receptors (CAR) targeting tumours have evolved rapidly
from a basic scientific tool to a new way in which we induce remission in patients
with very poor risk cancer.The synergy between basic and translational science
continues to further boost the utility of immunotherapy and enhance its potency in
various forms of cancer. In my talk I will highlight recent developments in the field and
conclude with how correlative studies may contribute to the success of this therapy.
Lunch onYour Own
ADCs / ADC-BISPECIFIC COMBINATION
Philipp Müller, Ph.D., Project Leader, Biomedicine, University Hospital of Basel
14:05 A Plug-and-Play Approach to Antibody-BasedTherapeutics via a
Chemoselective Dual Click Strategy
Vijay Chudasama, Ph.D., Lecturer, Chemistry, University College London
There is clear demand for the construction of novel antibody-drug conjugate (ADC)
platforms that offer greater stability, homogeneity and flexibility. A significant step
towards the ideal platform for next generation antibody-based therapeutics is
presented. Our technology provides decorated antibody constructs that are highly
stable, with complete retention of antibody binding/structure post-modification. It
combines site-specific functionalisation with exceptional versatility via a facile native
disulfide targeted plug-and-play strategy.
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14:35Targeting of SolidTumours with Bi-Specifics and Bi-Specific
ADCs to Induce Novel Biologics and Drug-Like Properties
David Poon, Ph.D., Senior Director, External Research & Development and Alliances,
Zymeworks, Inc.
A robust, developable and manufacturable bi-specific platform will be discussed as
the foundation to engineer novel anti-solid tumour antibodies. Unlike combination
therapies, these bi-specifics demonstrate enhanced tumour decoration, tumour
diffusion and retention, internalisation, and effector functions. Supported with IND-
enabling in vivo efficacy studies, Zymeworks’ lead bi-specific and bi-specific ADC
programs will be presented.
15:05 Improving Potency and Stability of Antibody-Drug Conjugates
Pavel Strop, Ph.D., Associate Research Fellow, Protein Engineering, Rinat-Pfizer
Traditionally, most ADCs relied on chemical conjugation methods that yield
heterogeneous mixtures of a variable number of drugs attached at different positions
with an average of four drugs per antibody.The benefits of transglutaminase-
based site-specific drug conjugation in terms of stability, manufacturing, improved
therapeutic index and ability to generate high loaded ADCs will be discussed.
15:35 Advances and Applications of the Fleximer Platform Approach
to ADCs
Tim Lowinger, Ph.D., CEO, Mersana Therapeutics
One of the challenges in developing ADCs is achieving efficacy for low-expression
targets. One approach to overcome this limitation has been developed at Mersana,
utilising our unique Fleximer platforms. Examples and applications will be presented
to highlight the benefits of this approach to achieve greater efficacy and therapeutic
index for low expression.
16:05 Developability Assessment of ADCs – A Case Study
Lars Linden, Ph.D., Head, Protein Biochemistry, Global Biologics, Cell and Protein
Sciences, Bayer Healthcare
Developability analysis of antibodies and ADCs determines, together with cell line
productivity and cost-of-goods analysis, the manufacturing feasibility of a drug
candidate. A thorough biochemical & biophysical characterisation is performed
to analyse the intrinsic stability and technical robustness of clinical candidates.
Standardisation is ensured by a check of platform compatibility (DSP and analytics).
16:35 End of Conference
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BIOLOGICS DEVELOPMENT STREAM
2-3 November 2015 | SIXTH ANNUAL
Optimisation and Development of Biologics
Strategies for Candidate Selection and Enhancement of Product Properties
MONDAY 2 NOVEMBER
Darrell Sleep, Director, Novozymes Biopharma R&D
13:50 Protein Engineering for New Modes
of Actions and NewTargets
Andreas G. Plückthun, Ph.D., Professor & Director, Biochemistry,
Using different display technologies and structure-based engineering,
the possibilities of hitting extra- and intracellular targets will be
discussed, with an emphasis on extending the modes of action previously
possible. The lecture will emphasise the need for interdisciplinary approaches.
14:30Targeting Ion Channels
Tristan J. Vaughan, Ph.D., Senior Director, Antibody Discovery &
Protein Engineering, MedImmune Ltd.
Ion channels are complex integral membrane proteins that form a
pore through which ions selectively pass down an electrochemical
gradient. They are prominent components of the nervous system where
they can mediate transduction across synapses. Hence, certain channels
represent good drug targets, especially for alleviating pain. Approaches will be
described to target such ion channels with antibody-based drugs and a case
study presented.
15:10 Current and FutureTrends in AntibodyTherapeutics
Paul W.H.I. Parren, Ph.D., Senior Vice President & Scientific Director,
Preclinical Development & Research, Genmab
Targeted treatment using antibody therapeutics has proved
successful in the development of meaningful treatments in diverse
therapeutic areas. However, despite strong advances, many patients still fail
to respond or become resistant to targeted treatment and novel innovative
approaches to improve therapy are therefore required. Genetic and chemical
engineering of antibodies, fueled by recent molecular insights, is providing
important opportunities for the development of more potent antibody
therapeutics. Examples from Genmab’s portfolio will be provided.
CANDIDATE SELECTION
William Finlay, Ph.D., Senior Director, Global Biotherapeutics, Pfizer, Inc.
16:35 Purpose Oriented Antibody Libraries for de novo Generation of
pH-Dependent Antibodies
Some antibodies having unique characteristics such as pH-dependent antigen
binding are difficult to isolate using standard antibody generation platforms and thus
require extensive engineering. We have created several purpose-oriented antibody
libraries to facilitate the de novo isolation of candidates with characteristics such as
pH-dependent binding or enzyme neutralisation activity.
17:05 Augmented Binary Substitution: Simultaneous Ultra-
Humanisation, CDR Redundancy Minimisation and Stabilisation of
Antibodies for HumanTherapy
William Finlay, Ph.D., Senior Director, Global Biotherapeutics, Pfizer, Inc.
This study presents a technology that generates stable, soluble, ultra-humanised
antibodies via single-step CDR redundancy minimisation. For three antibodies from
three separate key immune host species, ABS processing significantly lowered non-
human sequence content, minimisedT and B cell epitope risk in the final molecules and
provided a heat map for the essential non-human CDR residue content of each antibody.
17:35 Veltis®Technology: Engineered Albumins for Sponsored by
Optimized Serum Half-Life Extension
Joanna Hay, Ph.D., Customer Solution Science Manager,
Novozymes Biopharma UK
Short circulatory half-life represents a major obstacle for many protein and
peptide-based therapeutics, resulting in increased dosing with the consequent
risk of side effects and reduced patient compliance. The half-life of therapeutic
can be significantly improved by conjugation or fusion to albumin, due to both
size and recycling via the neonatal Fc receptor (FcRn). We will describe rationally
engineered albumins with increased FcRn affinity and their application to improve
the pharmacokinetic properties of therapeutic candidates.
18:05 Welcome Reception in the Exhibit Hall
with Poster Viewing
TUESDAY, 3 NOVEMBER
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OPTIMISATION OF AFFINITY, SPECIFICITY AND POTENCY
08:40 Design of Bispecific Antibodies:Target Biology Determines
Optimal Valency of Binding Sites
Alain C. Tissot, Ph.D., Head, Immune Biology, Large Molecule Research, Pharma
Research and Early Development, Roche Innovation Center, Penzberg
Bispecific antibodies are attractive for multifactorial diseases and simplify
development over combination therapies, particularly when the targets are two
ligands. We provide data for two preclinical bispecific antibodies in RA targeting
ligands, demonstrating the value of varying the valency of binding sites in order to
fully exploit target biology and potency.
09:10 Exploiting the Advantages of Bicyclic PeptideTherapeutics
Christian Heinis, Ph.D., Professor, Institute of Chemical Sciences and Engineering,
Ecole Polytechnique Federale de Lausanne (EPFL)
My laboratory is developing antagonists based on bicyclic peptides by phage
display. The bicyclic peptides combine key qualities of antibody therapeutics (high
affinity and specificity) and advantages of small molecule drugs (access to chemical
synthesis, diffusion into tissue, various administration options). An update on
recently developed bicyclic peptides and their activities will be given.
Table 4: Alternative Protein Scaffolds: Lessons from the Past and
Future Expectations
Moderator: Christian Heinis, Ph.D., Professor, Institute of Chemical Sciences
and Engineering, Ecole Polytechnique Federale de Lausanne (EPFL)
Table 5: Engineering for Optimization
Moderator: Laura Lin, Ph.D., Director, Global BioTherapeutic Technologies,
Pfizer, Inc.
Table 6: ImprovingTherapeutic Antibody Formats
Moderator: Paul W.H.I. Parren, Ph.D., Senior Vice President & Scientific Director,
Preclinical Development & Research, Genmab B.V.
ENHANCEMENT OF CLEARANCE
11:20 pH and Calcium-Dependent Fully Human Biparatopic IgG
Antibody for Efficient Elimination of Soluble Antigen from Plasma
Eriko Murata, Master of Pharmacy, Research Scientist, Discovery Research, Chugai
Pharmaceutical Co. Ltd.
We have previously shown that calcium-dependent antigen-binding antibody
increases soluble antigen elimination by dissociating the antigen in the endosome.
Here we report on a novel strategy to further accelerate antigen elimination from
plasma in vivo. Identification and optimisation of calcium-dependent binding
biparatopic antibody which forms multimeric antibody-antigen complexes to
enhance binding to Fc receptors will be presented.
11:50 ARGX-113, A Novel Fc -BasedTherapeutic Approach for
Antibody-Induced Pathologies
Peter Ulrichts, Ph.D., Senior Scientist, ArGEN-x
ARGX-113 is a proprietary antibody fragment based on arGEN-X’ ABDEG™
technology. ARGX-113 works by preventing pathogenic autoantibodies from being
recycled, promoting their degradation and thereby clearing them from circulation.
Preclinical data in cynomolgus monkeys proved ARGX-113 to be highly effective
in rapidly eliminating pathogenic antibodies, while sparing the broader immune
response. The data support further clinical development of this novel therapeutic
approach in autoimmune disease management.
12:20 Epitope Binning, Mapping and Affinity Ranking Sponsored by
of 96 Antibody Supernatants
Richard B.M. Schasfoort, Ph.D., CSO, IBIS Technologies B.V.
The binding of an antibody to an epitope is innate and cannot be
engineered anymore. Therefore the selection of antibodies that bind to the right
functional epitope should be carried out as early as possible. Technology is now
available enabling binning, mapping and affinity ranking of up to 96 Ab-sups in one
unattended run.
Lunch onYour Own
13:20 Session Break
14:00 Desert Break in the Exhibit Hall with Poster Viewing
DEVELOPABILITY ASSESSMENT AND
PRECLINICAL EVALUATION
Frank Walsh, CEO, Ossianix and Professor, Kings College London
14:35 Early Stage Developability Assessment of Biotherapeutics
Laura Lin, Ph.D., Director, Global BioTherapeutic Technologies, Pfizer, Inc.
The presentation will describe an early stage molecular assessment platform
we established in-house to rank, select, and optimise biotherapeutic leads in
early discovery at Pfizer. I will be discussing our strategies of early screening for
biophysical properties for a given project, and triage down a few leads for more
in-depth developability assessment. I will share a specific case study highlighting
developability comparisons between different modalities and the impact on efficacy,
PK, and manufacturability.
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15:05 Preclinical Development of MGD010: A CD32BxCD79B Bispecific
DART for theTreatment of Autoimmune Disease.
Paul Moore, Ph.D., Vice President, Research, Cell Biology & Immunology,
MacroGenics, Inc.
MGD010, a bi-specific Dual-Affinity ReTargeting (DART) that inhibits B-cell activation
via colligation of the inhibitory FcγRIIb receptor CD32B with the BCR component
CD79B, is being developed as a novel therapeutic molecule for autoimmunity.
Studies performed to support MGD010 clinical development will be presented,
covering mechanism of action, therapeutic modeling, safety pharmacology and first-
in-human dose projection
15:35 Preclinical Studies with FynomAbs, Fynomer-Antibody
Fusion Proteins
Vanessa Baeriswyl, Ph.D., Scientist, Covagen AG, one of the Janssen
Pharmaceutical Companies of J&J
Bispecific FynomAbs are generated by fusing Fynomer binding proteins to
antibodies. The ability to fuse Fynomers to multiple sites on the antibody
allows the creation of therapeutics with higher potency and desired bioactivity,
since the efficacy of bispecifics is greatly influenced by the orientation of the
two binding sites relative to each other. Case studies of FynomAbs having
selective tumour killing properties will be presented, as well as key parameters,
such as manufacturability and yield (3.3 g/l obtained in 1000 liter GMP run),
pharmacokinetics and stability.
16:05 Presentation to be Announced
Sponsored by
with Poster Viewing
FORMULATION AND DELIVERY
17:15 Implementation of an Integrated High-Throughput Formulation
Screening for Biologics
Michael Siedler, Ph.D., Section Head, NBE Formulation Sciences & Process
Development, AbbVie Deutschland GmbH & Co KG
Modern formulation development increasingly relies on multivariate parameter
analysis in order to enable statistical analysis. Consequently, the only way to
generate and leverage the required vast amount of data is by applying appropriate
scale-down methodologies and lab automation in conjunction with an IT
infrastructure capable of transforming the data into knowledge. We will provide a
case study of how this can be achieved.
17:45 Delivery of Single Domain Antibody Biotherapeutics to the
Brain (NAB)
Frank Walsh, CEO, Ossianix and Professor, Kings College London
This presentation will describe the development of a toolkit of individual single
domain VNAR antibodies to the transferrin receptor 1 that bind with varying
affinities to multiple epitopes on the receptor. These allow the generation of
bispecific biotherapeutics that will cross the BBB via receptor-mediated endocytosis
at therapeutic doses and can be tailor-made for differing therapeutic modalities.
Studies showing direct translation from animal data to humans will be included.
18:15 Oral Delivery of Anti-TNF-Alpha Nanofitin Shows a Strong
Preventive and Curative Anti-Inflammatory Effect in Models of
Inflammatory Bowel Diseases
Mathieu Cinier, Ph.D., Scientific Director, Affilogic
Despite remarkable efficacy, treatment of IBD using systemic administration of
anti-TNF-alpha antibodies remains associated with serious adverse effects. Extreme
stability of the Nanofitins, novel alternative scaffolds, in the gut environment enable the
development of orally available anti-TNF-alpha therapeutics and allow better targeting of
the inflammation site while decreasing systemic exposure and related side effects.
18:45 End of Optimisation & Development
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Protein Aggregates and Particles
Tools and Techniques for Effective Prediction and Analysis of Aggregates and Particles
SC9: AdvancedTechniques for Characterisation of Protein
Aggregates, Particulates and Contaminants
ENGINEERING PROTEINTHERAPEUTICS
FOR REDUCED AGGREGATION
Salvador Ventura, Ph.D., Professor, Biochemistry and Molecular Biology, Institute of
Biotechnology and Biomedicine, University of Barcelona
08:35 Understanding (and Controlling) Aggregation of Antibody-
Drug Conjugates
Fred Jacobson, Ph.D., Staff Scientist, Kadcyla™ Technical Development
Leader, Protein Analytical Chemistry, Genentech, Inc.
09:20 Engineering Antibodies for Improved Developability Properties
Chris Lloyd, Ph.D., Senior Scientist, Antibody Discovery and Protein Engineering,
MedImmune
09:50 Stable Human AntibodyTherapeutics and Phage Display
Libraries through Engineering of Variable Domains
Daniel Christ, Ph.D., Associate Professor of Medicine; Head, Antibody Therapeutics,
Immunology Program, Garvan Institute of Medical Research
Human antibody variable domains often display poor biophysical properties and
a propensity to aggregate. We have identified aggregation hotspots in the CDR
regions of antibody variable VH and VL domains, and have developed generally
applicable strategies to overcome these limitations. Here we outline the
application of the technology to human antibody therapeutics and antibody phage
display libraries.
10:20 InnovativeTechnologies to Improve the Sponsored by
Characterization of Protein Aggregates
Matthew Brown, Ph.D., Scientist, Malvern Instruments Ltd.
Understanding the process of protein aggregation is a key
component of QbD approaches during biotherapeutic development or deviation
resolution of legacy products. Advanced characterization technologies, now available
to the biopharmaceutical industry, offer detailed insights into protein behavior to
improve product stability and process knowledge and understanding.
IMPACT OF AGGREGATION
ON FILLING AND FORMULATION
11:30 Challenges and Considerations Associated with Aggregation of
Biopharmaceuticals during Fill Finish Process Development,Transfer
and Commercialisation
Francis Carroll, Development Scientist,Technical Development, Genzyme Ireland Ltd.
Fill Finish processing of biopharmaceuticals presents numerous challenges for the
inhibition of aggregation. During filling operations, degradation induced by shear
stress, chemical and photo exposure, manifests itself in elevated levels of HMWS.
Furthermore, control of excipient state during lyophilisation is critical for maintaining
a protein in its native state, which can inhibit increases in aggregation during a
product’s shelf life.
12:00 Formulation Development Based on Sub-Visible Particle
Morphology Using Micro-Flow Imaging
Malin Persson, Ph.D., Senior Research Scientist, Biopharm Formulation
Development, Novo Nordisk A/S
Lunch onYour Own
13:30 Session Break
MECHANISM OF PROTEIN AGGREGATION
Jennifer McManus, Ph.D., Lecturer, Department of Chemistry, National University
of Ireland Maynooth
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14:05 Understanding Protein Aggregation in Pharmaceutical Products
Jun Liu, Ph.D., Senior Group Leader and Principle Scientist, Genentech, Inc.
Protein aggregates are common degradation products for therapeutic proteins. Due
to the complex nature of protein aggregation, the underline mechanisms and their
potential biological impacts are not always well understood. In this presentation, we
will give an overview of protein aggregation phenomenon for a few pharmaceutical
products. The mechanism and implication of these protein aggregates will be
reviewed and discussed.
14:35 Aggregation Analysis at High and Low Protein Concentrations
of Ireland Maynooth
Aggregation of proteins may occur by a number of different mechanisms, which
can lead to a range of aggregate types. Using a range of analytical techniques the
formation of protein aggregates by various mechanisms has been assessed at
low and where possible, at moderate to high protein concentrations. The effect of
sugars on protein stability will also be discussed.
15:05 Effects of Protein Aggregation on Uptake, Processing and
Presentation by Dendritic Cells – A Case Study
Anja Langenkamp, Ph.D., Principal Scientist, Immunopathology, Pharmaceutical
Sciences, Roche Pharmaceutical Research & Early Development, Roche Innovation
Center Basel
Studies show that tolerance can be broken in transgenic mouse models by harshly
stressed protein therapeutics. However, the underlying mechanisms and relevance
for humans remain unclear. Thus, we studied the influence of aggregation on
the uptake, presentation and activation of dendritic cells - the key regulators
for adaptive immunity. First results will be presented that provide mechanistic
insights into the properties of monomeric and aggregated variants of a therapeutic
monoclonal antibody.
MODELING AND PREDICTION
OF AGGREGATION PROPENSITY
16:15Tuning the Aggregation Propensity of Protein Structures
This talk presents a method to overcome the current limitations of predicting
aggregation by sequencing. The AGGRESCAN3D (A3D) server overcomes the
limitations by taking into account the protein structure and the experimental
aggregation propensity scale. The identified aggregation-prone residues can be
virtually mutated to design variants with increased solubility. Additionally, the A3D
server takes into account the dynamic fluctuations of protein structure in solution,
which may influence aggregation propensity.
16:45 Rational Design of Protein Solubility
MicheleVendruscolo, Ph.D., Professor, Department of Chemistry, University of Cambridge
I will discuss the extent to which the solubility and aggregation of proteins are
related to the physico-chemical properties of their amino acid sequences. Based
on these properties, I will present methods for the prediction of the solubility
and aggregation of proteins and illustrate how these methods can be of practical
interest and importance.
17:15 Determinants and Impact of Antibody Aggregation on
Production and Application
Joost Schymkowitz, Ph.D., Professor, VIB Switch Lab, Department of Cellular and
Molecular Medicine, KULeuven
As most proteins, antibodies have a propensity to aggregate that is determined by
their primary sequence and aggregation acts as a bottleneck on both production
and application. Accurate prediction of antibody quality is currently lacking but
would be of value to help identify good antibodies. I will discuss a number of key
determinants and how to employ them for this purpose.
17:45 Standards, Measurements, and Analysis for Protein Particle
Characterization
Richard Cavicchi, Ph.D., Scientist, Bioprocess Measurements Group, National
Institute of Standards and Technology
Concentration measurements of protein aggregates obtained on orthogonal
instrument types often differ significantly. NIST is developing a protein aggregate
standard that simulates aggregate properties for sizes from 1 µm to visible particles.
In addition, we are using a custom microfluidic device that compares orthogonal
measurements on single particles to analyze microfabricated particles of defined
dimensions and protein aggregates to discern the effects of shape and porosity.
19:15 End of Day
METHODS FOR DETECTING, IDENTIFYING AND
CHARACTERISING AGGREGATES & PARTICLES
Antonio Ribeiro, Ph.D., Professor, Pharmaceutical Technology, University of Coimbra
Azinhaga de Santa Comba
08:35 NanoparticleTracking Analysis for Studying Aggregation Profile
of Particles
Subvisible particles do not constitute a mass fraction to be quantified by using
size exclusion chromatography (SEC). Moreover, SEC requires high dilution of the
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sample, which itself can change the aggregation profile. Nanoparticle tracking
analysis (NTA) can count and measure size individual species in undiluted particles
and may be more appropriate than SEC for studying particles aggregation.
Moreover, using fluorescent labeled particles, NTA may allow distinguishing
individual from aggregated particles.
09:05 Hydrodynamic Diameter (By DLS) and Molecular Mass
Measurement (By SLS After FFF) Can Characterise Aggregation Level
of A HMW Protein Not Characterisable by SE-HPLC
Peter Matthiessen, Ph.D., Senior Manager, Formulation, Fill/Finish, Baxter Innovations
GmbH
The aggregation level of a HMW Protein cannot be quantified by SE-HPLC. Field
flow fractionation can partially separate potential aggregates and SLS was used
for quantitation of molecular mass increase. Also DLS was used to monitor
hydrodynamic diameter increase by potential aggregates. Various temperature
stress conditions in liquid and lyophilized form and mechanical stress by shaking or
stirring, both known to induce aggregation, were investigated by DLS and SLS. The
correlation of aggregation and subvisible particle levels was investigated.
09:35 New, Orthogonal Methods to Detect Protein Aggregation at
High and Low Concentration
Tudor Arvinte, Ph.D., Chairman & CEO, Therapeomic, Inc.
Based on case studies, different orthogonal methods will be presented that permit
detection and characterisation of protein aggregates and particulate matter in liquid
formulations of biopharmaceuticals at high and low a protein concentrations. A
method alone cannot provide absolute information on the aggregates present in
a sample. By using different methods to analyse a sample, we can obtain strong
conclusions and a broad picture on the protein aggregation states and particulates
present in the solutions.
10:05 Protein-Protein Interactions, in Multi Protein- Sponsored by
Albumin or Peptide-Albumin Co-Formulations Using
Recombinant Human Serum Albumin (rHSA) to
Prevent Aggregation
Jens Thostrup Bukrinski, Ph.D., Senior Scientist, Biopharma R&D, Novozymes A/S
It is well-known that rHSA has the ability to prevent protein and peptide
aggregation. At drug concentrations <1mg/mL coating of hydrophobic and
hydrophilic surfaces of the primary packaging material and process equipment is
expected to prevent depletion and surface induced aggregation. When aggregation
is independent of the surfaces (>1mg/mL) the mechanism of aggregation
prevention is less well understood and is likely to depend on the aggregation
pathway of the drug. Some case studies suggest that hydrophobic patches on rHSA
interact with hydrophobic patches on the drugs forming an rHSA-drug complex
where such surface areas are shielded and hereby preventing self-association.
Other case studies suggest an excluded volume effect with no rHSA-drug
complex formation.
10:35 Coffee Break in the Exhibit Hall
with Poster Viewing
11:15 Detection and Characterisation of Visible, Sub Visible Particles
and Other Aggregates: Achievements and Challenges
Anacelia Rios Quiroz, MSc, Late Stage Pharmaceutical and Process Development,
Pharmaceutical Development & Supplies, PTD Biologics Europe, (PTDE-PF), F.
Hoffmann-La Roche, Ltd.
The talk will give an overview of required and commercially available counting
methodologies for detection of protein aggregates and visible and sub visible
particles (SbVP); species ubiquitously present in protein formulations. Focus will be
SbVP as they are gaining attention regarding immunogenicity and quality attributes.
Lack of a well-defined methodology for SbVP makes it important to increase
our knowledge of emerging instruments’ performance. Applicability towards the
assessment of a meaningful array of particle counting techniques will be discussed.
11:45 Chemical Kinetics and Microfluidic Sizing for the Analysis of the
Aggregation ofTherapeutic Proteins
Paolo Arosio, Ph.D., Marie Curie Postdoc Fellow, Department of Chemistry,
University of Cambridge
In this presentation, we show how chemical kinetic analysis can identify the protein
aggregation path-ways at the molecular level. We demonstrate the potential of this
approach by analyzing the aggregation mechanisms of different IgGs and of human
insulin under conditions that are relevant for downstream and formulation. Finally,
we show a novel microfluidic technique that enables the sizing of polydisperse
protein samples under native conditions on a second timescale.
Lunch onYour Own
13:30 End of Protein Aggregates & Particles
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Analytical Characterisation of Biotherapeutics
Methods & Strategies for Better Developability and Manufacturability of Molecules
12:30 Registration
Roman A. Zubarev, Ph.D., Professor, Division of Chemistry I; Head, Department
of Medical Biochemistry & Biophysics, Karolinska Institutet
13:35 Massive de novo Sequencing of IgG Variants in Human Blood
by Mass Spectrometry
Roman A. Zubarev, Ph.D., Professor, Division of Chemistry I; Head,
Department of Medical Biochemistry & Biophysics, Karolinska Institutet
The traditional proteomics assay is complemented by profiling both IgGs
and co-extracted proteins using de novo sequencing by HCD and ETD MS/
MS. Each of these two additional domains (IgGs and co-extracted proteins) adds at
least as much information to patient stratification as the direct proteomics assay.
New IgG peptides discovered by de novo sequencing contribute significantly to the
predictive power of IgG-omics, and are potentially indicative of the disease etiology.
EARLY-STAGE VS. LATE-STAGE CHARACTERISATION
14:20 Biophysical Characterisation for Selection of Robust Humanised
Therapeutic Antibody Candidates
Alison Turner, Group Leader, Biophysics, Biology, UCB Celltech
Panels of humanised antibodies from UCB’s new Core Discovery Platform are
transiently expressed and purified, then screened using a number of assays and
biophysical techniques to select therapeutic candidates with optimal chemical and
physical stability. This process provides early information on ‘manufacturability’
by reducing the aggregation risk during different purification steps (shear stress,
buffer effects) and confidence in the stability of the drug product during storage and
administration (high concentration effects).
14:50 Computational Approaches to Optimise Sponsored by
Antibody Efficacy & Pharmaceutical Developability as
Therapeutic Agents
Anne Goupil-Lamy, Principal Field Application Scientist, BIOVIA Science Council
Fellow, BIOVIA
We will present how the convergence of BIOVIA capabilities supported by a
common platform can be designed to help with the discovery and optimization of
biotherapeutic candidates, in particular the management and analysis of all scientific
and quality data generated throughout the process. We will highlight predictive
analysis in Discovery Studio for early candidate selection and optimization. This
includes high throughput antibody annotation and structure prediction, developability
assessment to help improve stability, solubility and viscosity.
16:05 Characterisation of Acidic Species in Monoclonal Antibody
Li Zang, Ph.D., Senior Scientist, Analytical Development, Biogen
Acidic species in monoclonal antibody are highly heterogeneous and challenging for
detailed characterization. They may post impacts on the function and stability of the
monoclonal antibody. A detailed characterization of acidic species in a monoclonal
antibody biopharmaceutical will be presented in this talk. The potential impact of
acidic species on function and stability of the antibody will be discussed.
16:35 Late-Stage Characterisation of aTherapeutic Enzyme
Peter Bernhardt, Ph.D., Senior Scientist, Analytical Development, Shire
An approach for late-stage characterization will be discussed that focuses on critical
quality attributes.This approach includes developing a comprehensive understanding
of product-derived substances and impurities formed during manufacturing and under
relevant storage conditions, as well as structure elucidation of product variants and
understanding of structure/function relationships. A complex glycoprotein used for
enzyme replacement therapy will be used as an example.
17:05 End of Day
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FRIDAY, 6 NOVEMBER
HIGHTHROUGHPUT CHARACTERISATION AND
BIOASSAY DEVELOPMENT
Vishal Kamat, Ph.D., Scientist, Biomolecular HTS Center, Therapeutic Proteins,
Regeneron Pharmaceuticals
08:35 High-Throughput Label-Free SPR Binding Kinetics Assay for the
Characterisation of Fully HumanTherapeutic Antibodies
Vishal Kamat, Ph.D., Scientist, Biomolecular HTS Center, Therapeutic Proteins,
Regeneron Pharmaceuticals
Most of the biosensors today have limited throughput capacity and are unconducive
to perform high-throughput affinity screening of mAbs. In an effort to support
Regeneron’s therapeutic antibody drug discovery, we have successfully optimized
the affinity screening methods to expand the throughput capability using Biacore
4000 and MASS-1, beyond originally anticipated from these two instruments.
Strategies adopted to increase throughput and comparability of the binding rates
constants measured using this modified techniques will be presented.
09:05 Analysis of Classical and Novel Biotherapeutics with High-
Throughput MCE Assays
Stefanie Wohlrab, Ph.D., Post-Doc, Pharma Technical Development, Roche
Diagnostics GmbH
Continuous process automation and Design of Experiments (DoE) increase the number
of samples that need to be processed. Microchip capillary electrophoresis (MCE)
provides a high-throughput platform to monitor product quality. Here, we demonstrate
the use of Perkin Elmer´s LabChip GXII platform to characterize as well as to monitor
antibody fragments during bioprocessing.The MCE assay shows a good linear range,
high sensitivity and provides a resolution superior to CE-SDS for some aspects.
09:35 Bioassays to Quantify aTherapeutic Fc-Fusion Protein in
Preclinical Studies
Kelly Loyet, Ph.D., Scientist, Biochemical and Cellular Pharmacology, Genentech, Inc.
Pre-clinical studies were performed to evaluate the pharmacokinetics and efficacy of
a potential therapeutic Fc-fusion protein. This talk will summarize the development
of bioassays to quantify the pharmacokinetics of the therapeutic protein as well
as markers of its pharmacodynamics. Due to a large number of studies performed
and low concentration dosing groups, assays were optimized for efficiency and
sensitivity. Both mouse and cynomolgus monkey studies will be discussed.
10:05Trending and StatisticalTools for the Consistent Monitoring of
Bioassay Characteristics
Erica Bortolotto, Ph.D., Scientist, Bioassay Development, Analytical Sciences for
Biologics, UCB Pharma SA
How to monitor a method’s performance over time? Which parameters should be
trended? How to ensure a continuous validation of the method or the assessment
of the right concentration for critical reagents or the bridging between reference
standards? This talk will present an overview of the problems via case studies
presenting trending and statistical tools.
CHARACTERIZATION OF COMPLEX MOLECULES
AND NOVEL FORMATS
11:00 Method for Postsynthetic Characterisation of Multi Antibody
Polymalic Acid Conjugates
Eggehard Holler, Ph.D., Professor & Research Scientist III, Neurosurgery, Cedars-
Sinai Medical Center
The method enables us to characterize arrays of multiple different antibodies
covalently attached to biopolymalic acid based multifunctional nanoconjugates.
The technology applies mild ammonolysis for cleavage which leaves proteins in
their native state. Antibody content and multiple target (antigen) binding activities
are validated by antibody structure and target (antigen) binding analysis using
quantitative ELISA and size exclusion HPLC before and after specific cleavage and
degradation of the polymalic acid platform.
11:30 Analytical Methods to Characterise Bispecifics
Samadhi Vitharana, Ph.D., Principal Scientist, Core Sciences & Technology,
Takeda California
12:00 Understanding Size Dependence of Rabbit Vitreal Clearance
Whitney Shatz, Ph.D., Senior Research Associate, Protein Chemistry, Genentech, Inc.
Due to the relatively rapid clearance of protein drugs from the eye following
intravitreal administration, maximal efficacy requires frequent dosing, typically
monthly or bi-monthly. Although there is some data suggesting molecular
weight (MW) may be important to vitreal clearance and ocular tissue distribution,
systematic protein studies have not been performed. Using a rabbit ocular model,
we tested this hypothesis to further our understanding of ocular pharmacokinetics.
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12:30 High-Throughput Characterisation of Sponsored by
Monoclonal Antibodies Using the Fortebio Octet HTX
Jesper Pass, Ph.D., Principal Scientist, Novo Nordisk A/S
In order to meet an increasing demand for antibodies
for therapeutic use and as research reagents, a state of the art automated
workflow for high throughput generation of monoclonal antibodies (mAbs) has
been established. With an increase in the number of antibodies generated,
comprehensive characterization of large panels of antibodies is essential to ensure
early selection of mAbs with the desired properties for further development. In
order to ensure high throughput characterization, we utilize label-free Bio-Layer
Interferometry (BLI) analysis performed on a Fortebio Octet HTX instrument.
The Octet HTX has been implemented in the screening for specific binders, and
characterization of selected mAbs with regards to affinity and epitope binning. The
instrument is further used for selection and prioritization of high expressing clones
in production cell-line development. Examples of the use of the Octet HTX in the
automated high throughput mAb generation process will be presented.
13:00 Luncheon Presentation
(Sponsorship Opportunity Available) or Lunch onYour Own
13:30 Session Break
NEW APPROACHES AND NOVELTECHNIQUES FOR
PRODUCT AND PROCESS CHARACTERISATION
Huijuan Li, Ph.D., Director, Analytical Development, Biologics Bioprocess
Development, Merck Research Laboratories
14:05 Multi-Angle Effector Function Analysis of Human Monoclonal
IgG Glycovariants
Tilman Schlothauer, Ph.D., Senior Scientist, Biochemical and Analytical Research,
Large Molecule Research, Roche Pharma Research and Early Development (pRED),
Roche Innovation Center Penzberg
To assess Fc functionality, many different approaches for characterization exist, more
or less reflecting the physiological mechanism of Fc receptor recruitment. Here we
combined different ways to measure Fc functionality. In addition to classical antibody
Fc receptor interaction studies of eight different enzymatically engineered IgG1
glycosylation variants, we analyzed also the behavior of these variants as a preformed
immune complex on the new developed Fc Receptor affinity chromatography.
14:35 High-Throughput Glycoprofiling via glyXbox: A High-
Performance Glycoanalysis-System Based On xCGE-LIF
Erdmann Rapp, Dr. rer.nat., Head, Bio/Process Analytics, Max Planck Institute for
Dynamics of Complex Technical Systems
We have developed a glycoanalysis approach, based on multiplexed capillary
gelelectrophoresis with laser induced fluorescence detection (xCGE-LIF), which
shows high potential for high-performance analysis of glycoconjugates. The
applicability of the system is demonstrated for different types of glycosamples
(biopharmaceuticals, vaccines, human milk and blood serum). This novel modular
high-performance glycoanalysis system allows fully automated, highly sensitive,
instrument-, lab- and operator-independent “real” high-throughput glycoanalysis, a
contrast to the prevailing costly and lab-space intensive methods.
15:05 Characterisation of Process Impurities, Product Variants, Post
Translational Modifications for Biologics
Huijuan Li, Ph.D., Director, Analytical Development, Biologics Bioprocess
Development, Merck Research Laboratories
Multiple case studies will be discussed on characterization of recombinant
monoclonal antibody (mAb) drugs and their degraded and/or post-translationally
modified counterparts, drug product- related impurities and variants for successful
development of biotherapeutics.
15:35 New Analytical Approaches in Process Development and
Product Characterisation
Alok Sharma, Ph.D., Head, Analytical Development, Lupin Pharmaceuticals
16:05 Exploring the Generation of Variants in QbD
James Sutter, MSc, MBA, Associate Manager, Biotech Process Sciences,
Downstream Process, Merck Serono
This talk will define QbD and its main components such as TPP, CQA, CPP, process
characterisation, process & product knowledge, control strategy and design space.
In the frame of QbD, optimising quality of biologics by generation, separation
and characterisation of variants is key for product and process understanding.
This presentation shows case studies on isolation and characterization of low &
high molecular weight and charge antibody variants to explore various separation
techniques for clearance.
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IMPURITIES & STABILITY STREAM
2-3 November 2015 | INAUGURAL
Protein Purification Technologies
Achieving Purity & Quality
Prone to Aggregate
MONDAY, 2 NOVEMBER
13:50 Streamlining Protein Expression & Production
Lorenz M. Mayr, Ph.D., Vice President & Global Head, Reagents &
Assay Development, Innovative Medicines/Discovery Sciences,
AstraZeneca
14:30 Mechanically Refolding Proteins beyond Unboiling an Egg
Gregory A. Weiss, Ph.D., Professor of Chemistry, Molecular Biology
and Biochemistry, University of California, Irvine
Traditionally, refolding proteins involves arduously optimising conditions
to coax protein solution into thermodynamic equilibrium. Using a Vortex
Fluid Device, my lab has applied shear stress during refolding to overcome barriers
between protein folding states, rapidly driving refolding. For processes not dialysis-
dependent, this accelerated refolding allows a more thorough search for conditions
favoring protein stability. We have demonstrated VFD-based protein refolding on
recombinant proteins, plus refolded lysozyme from boiled egg whites.
15:10 INTERACTIVE PANEL DISCUSSION:
EmergingTechnologies and Methods to ImproveYields
New technologies and approaches are leading to greater yields and greater
efficiencies for analyzing quality. This panel discussion examines which
technologies show the greatest promise, and discusses how these new
methods will innovate the field of protein science. Discussion topics include:
• High-throughput
• Parallel expression/purification
• Purity
• Automation
• Protein folding
• Assays
• Cell line engineering
Panelists:
Additional Panelists to be Announced
PURIFYING ANTIBODIES
Dirk Linke, Ph.D., Professor, Molecular Microbiology, Biosciences, University of Oslo
16:35 Magnetically-Driven HybridTechnologies for Antibody
Purification
Ana Cecília Afonos Roque, Ph.D., Assistant Professor, Chemistry, UCIBIO,
Faculdade de Ciências e Tecnologia, Universidade Nova de Lisboa
Two magnetically-driven hybrid technologies have been recently proposed by our
group as novel alternatives for non-chromatographic antibody purification. One
approach concerns with the incorporation of magnetic particles into macroporous
structures to confer a magnetic response to the new composites. This magnetic
response was explored for accelerated and efficient protein elution. In a second
approach, the potential to combine aqueous two-phase extraction with magnetic
separation was explored with success.
17:05 Purification of Common-Light-Chain Bispecific Antibodies
Juergen Nett, Ph.D., Associate Director, High Throughput Expression, Adimab LLC
A variety of bispecific constructs benefit from the use of a single variable
light region pairing with multiple distinct variable heavy regions. This talk will
demonstrate new techniques to purify these common-light-chain bispecific IgG
molecules to homogeneity. A panel of bispecific constructs are then generated that
bind to each target with high affinity and exhibit favorable biophysical properties
similar to traditional therapeutic antibodies.
TUESDAY, 3 NOVEMBER
PURIFYING MEMBRANE PROTEINS
Karin Felderer, Ph.D., Associate Director, Protein Production, Protein Sciences,
MorphoSys AG
08:40 Bacterial Membrane Separation, Fractionation and
Solubilization as Essential Steps in Membrane Protein Purification
We strive to compare and improve different protocols for the fractionation of
proteins from Gram-negative bacteria into outer membrane, cytoplasmic membrane,
periplasmic, and cytosolic fractions. I will compare 5 methods for membrane
fractionation, and will discuss downstream processing and protein purification. I will
also show recent data on fluorescence labeling of different membrane systems,
that we use to track yield and purity of our membrane samples.
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09:10 GPCR Structural Biology: A Case Study with a Novel Fluorescent
Fusion Partner
Saurabh Sen, Ph.D., Principal Scientist, Immune Modulation and NBE Discovery,
Boehringer Ingelheim Pharmaceuticals, Inc.
Structural biology of membrane proteins and GPCRs has seen major advances over
the past few years, but overcoming the challenges of functional GPCR expression and
structural stabilization are still time-consuming and expensive.The talk will focus on
an approach that combines a powerful cloning strategy with novel transmembrane
guides and a novel fluorescent reporter which significantly increases functional
receptor expression in E. coli along with other downstream processing benefits.
Table 7: Bottlenecks in the Purification of Biotherapeutics
Moderator: David O’Connell, Ph.D., Lecturer & Director, MSc Programmes in
Biotherapeutics, Biomolecular & Biomedical Research, University College Dublin
Table 8: Systems for GPCR Expression: HaveWe Identified the BestYet?
Moderator: Saurabh Sen, Ph.D., Principal Scientist, Immune Modulation and
NBE Discovery, Boehringer Ingelheim Pharmaceuticals, Inc.
Table 9:Transition of Projects from Discovery to Development:
What are Important Points to Consider or Lessons Learned?
Moderator to be Announced
AFFINITY PURIFICATION
11:20 Recombinant Production and Utilization of Affinity of Proteins
Sophia Hober, Ph.D., Professor, Protein Technology, Biotechnology, KTH Royal
Institute of Technology
Strategies for optimization of protein production and purification will be presented
as well as a miniaturized high throughput method for protein verification. Fusion
tags for improved selectivity of protein purification processes including protein
domains with dual affinity will be presented. The dual affinity design can be of
advantage for protein purification as well as other applications where affinity to
more than one target molecule can be of value. Moreover, a novel, affinity-based
method, that renders site-specific labeling of antibodies possible will be discussed.
11:50 Application of a Novel Fragment Complementation-Based Affinity
System for Improved Protein Purification in a Single Step – from Highly
Soluble to Membrane Proteins andTherapeutic Binder Molecules
David O’ Connell, Ph.D., Lecturer & Director, MSc Programmes in Biotherapeutics,
Biomolecular & Biomedical Research, University College Dublin
In this presentation the performance of a novel EF hand-based fragment
complementation system will be highlighted for the purification of GFP, carbonic
anhydrase, GPCR and DARPin binder proteins. The application of a single-step
purification rationale will be compared to tandem affinity purification approaches and
downstream assays will be described.
Lunch onYour Own
13:20 Session Break
OVERCOMING PURIFICATION CHALLENGES
14:35 Case Studies: IDPs “Intrinsically Disordered Proteins,” Difficult
to Produce, but with a Significant Role in Cellular Pathways
Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Centre for Applied
Structural Biology, Institute of Chemistry,The Hebrew University of Jerusalem
Disordered domains in IDPs “Intrinsically disordered proteins” or IDRs “Intrinsically
disordered regions” play a significant role in cellular pathways, with an enormous
potential as medical targets. Because of their lack of stable tertiary structure and
their dynamic interchanging extended and flexible conformations, these types
of proteins are prone to aggregate, and constitute an extraordinary challenge to
produce. We’ll briefly illustrate here our strategy to produce enough amounts of
these type of targets for biophysical and biochemical studies that allows us to show
the way by which such domains act.
15:05 HighYield Expression of Protein Kinases in Insect Cells
Svend Kjaer, Ph.D., Head, Protein Purification, Structural Biology Science Technology
Platform, Francis Crick Institute
Baculovirus mediated infection of insect cells is a well-established technology for
production of proteins with many end-point applications. In this presentation, I’ll
present data on the expression and purification of a kinase target and demonstrate
the importance of co-expression strategies for downstream success. Moreover,
data on a generic method, which significantly improves yields by infection of insect
cell at high cell densities will be presented.
15:35 How to Get the High Hanging Fruits –Tools for Generation of
Difficult-to-Express Antigens
MorphoSys AG
A critical but often unaccounted factor in successful discovery and development of
therapeutic antibodies is the availability of high quality antigens and tool proteins
in sufficient amounts. The presentation will focus on the development of a novel
lysozyme-based expression/purification tag system allowing us to produce difficult-
to-express proteins of high quality as soluble monomers. Diverse case studies on
expression of human CD19, Fc receptors and other proteins will be presented.
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16:05 Native and Stabilized Membrane Proteins Sponsored by
for Drug Discovery
Anass Jawhari, Ph.D., CSO, CALIXAR
CALIXAR has developed patented technology based on new chemistry approach
to safely isolate membrane proteins (GPCR, ion channels, transporters, enzymes
and viral proteins) for drug discovery (antibody development, ligand screening,
SBDD and vaccine application).The presentation will illustrate some case studies
including Adenosine receptor A2A that was solubilized and purified without any single
mutation, truncation or fusion for antibody development purposes and crystallization.
INNOVATING PURIFICATION PROCESSES
17:15 Robust Design of Continuous Purification of AdenovirusVectors
byTwo-Column, Simulated Moving-Bed, Size-Exclusion Chromatography
José Paulo Mota, Ph.D., Professor, Chemical and Biochemical Engineering, Animal
Cell Technology, iBET & FCT-Universidade Nova de Lisboa
A two-column simulated moving-bed (2CSMB) process for continuous purification
of adenoviral vectors by size-exclusion chromatography is presented and validated
experimentally, and a general procedure for its robust design under parameter
uncertainty is described. The pilot-scale runs yield a virus recovery of 86% and
impurity clearance of 90% without any fine-tuning of the operating parameters. This
yield is 60% better and the productivity is increased by 6-fold with respect to single-
column batch chromatography for the same volume of resin.
17:45 Estimating Protein Phase Behavior Based on Osmotic Virial
Coefficients – AThermodynamics-Based Approach
Christian Kress, Dipl.-Ing, Scientist, Biochemical and Chemical Engineering,
Laboratory of Thermodynamics, Technical University of Berlin
Currently product capturing within protein production is often based on Protein-A
chromatography, limited in capacity and scalability, which leads to a demand for
different workup strategies (e.g. extraction by ATPS or precipitation). In order to enable
estimations on the applicability of these workup strategies, models to calculate partition
coefficients or protein solubility are required.Therefore a new estimation strategy based
on the second osmotic virial coefficients B22 and B23 is used.
18:15 Purification ofTherapeutic Proteins under Cost Constraints
Stefan Schmidt, Ph.D., Vice President, Process Science & Production, Rentschler
Biotechnologie GmbH
Biologicals and biosimilars represent the fastest growing segment in the drug
pipeline. This puts a lot of pressure on economical manufacturing, primarily solving
efficiency issues in downstream processing. Here I demonstrate how to solve
challenges by applying disposables, using modular concepts, replacing costly
affinity resins and reducing the number of steps in platform processes. The case
studies with examples from various molecule classes highlight successful process
design, optimization strategies and critical manufacturing parameters.
18:45 End of Protein PurificationTechnologies
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ENGINEERING PROTEINTHERAPEUTICS
FOR REDUCED AGGREGATION
08:35 Understanding (and Controlling)Aggregation ofAntibody-
Drug Conjugates
Fred Jacobson, Ph.D., Staff Scientist, Kadcyla™ Technical Development
Leader, Protein Analytical Chemistry, Genentech, Inc.
09:20 Engineering Antibodies for Improved Developability Properties
Chris Lloyd, Ph.D., Senior Scientist, Antibody Discovery and Protein Engineering,
MedImmune
09:50 Stable Human AntibodyTherapeutics and Phage Display
Libraries through Engineering of Variable Domains
Daniel Christ, Ph.D., Associate Professor of Medicine; Head, Antibody Therapeutics,
Immunology Program, Garvan Institute of Medical Research
Human antibody variable domains often display poor biophysical properties and a
propensity to aggregate. We have identified aggregation hotspots in the CDR regions
of antibody variable VH and VL domains, and have developed generally applicable
strategies to overcome these limitations. Here we outline the application of the
technology to human antibody therapeutics and antibody phage display libraries.
10:20 InnovativeTechnologies to Improve the Sponsored by
Characterization of Protein Aggregates
Matthew Brown, Ph.D., Scientist, Malvern Instruments Ltd.
Understanding the process of protein aggregation is a key
component of QbD approaches during biotherapeutic development or deviation
resolution of legacy products. Advanced characterization technologies, now available
to the biopharmaceutical industry, offer detailed insights into protein behavior to
improve product stability and process knowledge and understanding.
IMPACT OF AGGREGATION
ON FILLING AND FORMULATION
11:30 Challenges and Considerations Associated with Aggregation of
Biopharmaceuticals during Fill Finish Process Development,Transfer
and Commercialisation
Francis Carroll, Development Scientist,Technical Development, Genzyme Ireland Ltd.
Fill Finish processing of biopharmaceuticals presents numerous challenges for the
inhibition of aggregation. During filling operations, degradation induced by shear
stress, chemical and photo exposure, manifests itself in elevated levels of HMWS.
Furthermore, control of excipient state during lyophilisation is critical for maintaining
a protein in its native state, which can inhibit increases in aggregation during a
product’s shelf life.
12:00 Formulation Development Based on Sub-Visible Particle
Morphology Using Micro-Flow Imaging
Malin Persson, Ph.D., Senior Research Scientist, Biopharm Formulation
Development, Novo Nordisk A/S
Lunch onYour Own
13:30 Session Break
MECHANISM OF PROTEIN AGGREGATION
of Ireland Maynooth
14:05 Understanding Protein Aggregation in Pharmaceutical Products
Jun Liu, Ph.D., Senior Group Leader and Principle Scientist, Genentech, Inc.
Protein aggregates are common degradation products for therapeutic proteins. Due
to the complex nature of protein aggregation, the underline mechanisms and their
potential biological impacts are not always well understood. In this presentation, we
will give an overview of protein aggregation phenomenon for a few pharmaceutical
products. The mechanism and implication of these protein aggregates will be
reviewed and discussed.
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14:35 Aggregation Analysis at High and Low Protein Concentrations
of Ireland Maynooth
Aggregation of proteins may occur by a number of different mechanisms, which
can lead to a range of aggregate types. Using a range of analytical techniques the
formation of protein aggregates by various mechanisms has been assessed at
low and where possible, at moderate to high protein concentrations. The effect of
sugars on protein stability will also be discussed.
15:05 Effects of Protein Aggregation on Uptake, Processing and
Presentation by Dendritic Cells – A Case Study
Anja Langenkamp, Ph.D., Principal Scientist, Immunopathology, Pharmaceutical
Sciences, Roche Pharmaceutical Research & Early Development, Roche Innovation
Center Basel
Studies show that tolerance can be broken in transgenic mouse models by harshly
stressed protein therapeutics. However, the underlying mechanisms and relevance
for humans remain unclear. Thus, we studied the influence of aggregation on
the uptake, presentation and activation of dendritic cells - the key regulators
for adaptive immunity. First results will be presented that provide mechanistic
insights into the properties of monomeric and aggregated variants of a therapeutic
monoclonal antibody.
MODELING AND PREDICTION
OF AGGREGATION PROPENSITY
16:15Tuning the Aggregation Propensity of Protein Structures
This talk presents a method to overcome the current limitations of predicting
aggregation by sequencing. The AGGRESCAN3D (A3D) server overcomes the
limitations by taking into account the protein structure and the experimental
aggregation propensity scale. The identified aggregation-prone residues can be
virtually mutated to design variants with increased solubility. Additionally, the A3D
server takes into account the dynamic fluctuations of protein structure in solution,
which may influence aggregation propensity.
16:45 Rational Design of Protein Solubility
MicheleVendruscolo, Ph.D., Professor, Department of Chemistry, University of Cambridge
I will discuss the extent to which the solubility and aggregation of proteins are
related to the physico-chemical properties of their amino acid sequences. Based
on these properties, I will present methods for the prediction of the solubility
and aggregation of proteins and illustrate how these methods can be of practical
interest and importance.
17:15 Determinants and Impact of Antibody Aggregation on
Production and Application
Joost Schymkowitz, Ph.D., Professor, VIB Switch Lab, Department of Cellular and
Molecular Medicine, KULeuven
As most proteins, antibodies have a propensity to aggregate that is determined by
their primary sequence and aggregation acts as a bottleneck on both production
and application. Accurate prediction of antibody quality is currently lacking but
would be of value to help identify good antibodies. I will discuss a number of key
determinants and how to employ them for this purpose.
17:45 Standards, Measurements, and Analysis for Protein Particle
Characterization
Richard Cavicchi, Ph.D., Scientist, Bioprocess Measurements Group, National
Institute of Standards and Technology
Concentration measurements of protein aggregates obtained on orthogonal
instrument types often differ significantly. NIST is developing a protein aggregate
standard that simulates aggregate properties for sizes from 1 µm to visible particles.
In addition, we are using a custom microfluidic device that compares orthogonal
measurements on single particles to analyze microfabricated particles of defined
dimensions and protein aggregates to discern the effects of shape and porosity.
19:15 End of Day
METHODS FOR DETECTING, IDENTIFYING AND
CHARACTERISING AGGREGATES & PARTICLES
08:35 NanoparticleTracking Analysis for Studying Aggregation Profile
of Particles
Subvisible particles do not constitute a mass fraction to be quantified by using
size exclusion chromatography (SEC). Moreover, SEC requires high dilution of the
sample, which itself can change the aggregation profile. Nanoparticle tracking
analysis (NTA) can count and measure size individual species in undiluted particles
and may be more appropriate than SEC for studying particles aggregation.
Moreover, using fluorescent labeled particles, NTA may allow distinguishing
individual from aggregated particles.
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09:05 Hydrodynamic Diameter (By DLS) and Molecular Mass
Measurement (By SLS After FFF) Can Characterise Aggregation Level
of A HMW Protein Not Characterisable by SE-HPLC
Peter Matthiessen, Ph.D., Senior Manager, Formulation, Fill/Finish, Baxter
Innovations GmbH
The aggregation level of a HMW Protein cannot be quantified by SE-HPLC. Field
flow fractionation can partially separate potential aggregates and SLS was used
for quantitation of molecular mass increase. Also DLS was used to monitor
hydrodynamic diameter increase by potential aggregates. Various temperature
stress conditions in liquid and lyophilized form and mechanical stress by shaking or
stirring, both known to induce aggregation, were investigated by DLS and SLS. The
correlation of aggregation and subvisible particle levels was investigated.
09:35 New, Orthogonal Methods to Detect Protein Aggregation at
High and Low Concentration
Tudor Arvinte, Ph.D., Chairman & CEO, Therapeomic, Inc.
Based on case studies, different orthogonal methods will be presented that permit
detection and characterisation of protein aggregates and particulate matter in liquid
formulations of biopharmaceuticals at high and low a protein concentrations. A
method alone cannot provide absolute information on the aggregates present in
a sample. By using different methods to analyse a sample, we can obtain strong
conclusions and a broad picture on the protein aggregation states and particulates
present in the solutions.
10:05 Protein-Protein Interactions, in Multi Protein- Sponsored by
Albumin or Peptide-Albumin Co-Formulations Using
Recombinant Human Serum Albumin (rHSA) to
Prevent Aggregation
Jens Thostrup Bukrinski, Ph.D., Senior Scientist, Biopharma R&D, Novozymes A/S
It is well-known that rHSA has the ability to prevent protein and peptide
aggregation. At drug concentrations <1mg/mL coating of hydrophobic and
hydrophilic surfaces of the primary packaging material and process equipment is
expected to prevent depletion and surface induced aggregation. When aggregation
is independent of the surfaces (>1mg/mL) the mechanism of aggregation
prevention is less well understood and is likely to depend on the aggregation
pathway of the drug. Some case studies suggest that hydrophobic patches on rHSA
interact with hydrophobic patches on the drugs forming an rHSA-drug complex
where such surface areas are shielded and hereby preventing self-association.
Other case studies suggest an excluded volume effect with no rHSA-drug
complex formation.
10:35 Coffee Break in the Exhibit Hall
with Poster Viewing
11:15 Detection and Characterisation of Visible, Sub Visible Particles
and Other Aggregates: Achievements and Challenges
Anacelia Rios Quiroz, MSc, Late Stage Pharmaceutical and Process Development,
Pharmaceutical Development & Supplies, PTD Biologics Europe, (PTDE-PF), F.
Hoffmann-La Roche, Ltd.
The talk will give an overview of required and commercially available counting
methodologies for detection of protein aggregates and visible and sub visible
particles (SbVP); species ubiquitously present in protein formulations. Focus will be
SbVP as they are gaining attention regarding immunogenicity and quality attributes.
Lack of a well-defined methodology for SbVP makes it important to increase
our knowledge of emerging instruments’ performance. Applicability towards the
assessment of a meaningful array of particle counting techniques will be discussed.
11:45 Chemical Kinetics and Microfluidic Sizing for the Analysis of the
Aggregation ofTherapeutic Proteins
Paolo Arosio, Ph.D., Marie Curie Postdoc Fellow, Department of Chemistry,
University of Cambridge
In this presentation, we show how chemical kinetic analysis can identify the protein
aggregation path-ways at the molecular level. We demonstrate the potential of this
approach by analyzing the aggregation mechanisms of different IgGs and of human
insulin under conditions that are relevant for downstream and formulation. Finally,
we show a novel microfluidic technique that enables the sizing of polydisperse
protein samples under native conditions on a second timescale.
Lunch onYour Own
13:30 End of Protein Aggregates & Particles
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Protein Formulation and Stability
Overcoming Formulation Challenges with Advanced Techniques and Proven Strategies
12:30 Registration
FORMULATION APPROACHESTO MINIMISE
CHEMICAL DEGRADATION
Elizabeth M. Topp, Ph.D., Dane O. Kildsig Chair and Head, Department of Industrial
and Physical Pharmacy, Purdue University
13:35 Light-Induced Degradation and Aggregation of Antibodies
and Antibody Drug-Conjugates
Christian Schoneich, Ph.D., Takeru Higuchi Distinguished Professor and
Chair, Department of Pharmaceutical Chemistry, University of Kansas
Antibody-drug conjugates (ADCs) provide a promising approach to deliver
large payloads of toxic drugs. However, chemical and physical stability
problems of ADCs may arise from the exposure of ADCs to light, as
several ADCs contain drug conjugates, which may act as photosensitizer and drug
conjugation may change the general sensitivity towards light.This talk will focus
on product formation and mechanisms of light-induced degradation of antibodies
and model ADCs.
14:20 Practical Considerations in Screening Excipients for Protein Drugs
Andrea Ji, Ph.D., Senior Scientist, Genentech, Inc.
The presentation will address the critical factors to be considered in protein
formulation development such as oxidation, deamidation and excipient degradation
as well as mitigation strategies.
14:50 It’sTime to Start Dreaming About High Sponsored by
Throughput Screening! MultiplexYour
Measurements to Unlock Biologic Stability
Daniel Lund, Ph.D., Product Manager, Unchained Labs
The stability and characterization of biologics are crucial steps in the development of
modern medicines. Screening for and optimizing conditions used by biologics can
increase long-term stability and manufacturability. Bringing these measurements
into the pre-formulation stage de-risks development and aids in the selection of the
optimum candidate. However, achieving this has been challenging for many years
due to the lack of high-throughput, low sample consumption analytical tools. The
UNit, a unique and pioneering stability platform from Unchained Labs, overcomes
these inadequacies and allow researchers to develop stable proteins in optimal
formulations which can be more easily manufactured and stored for longer.
with Poster Viewing
16:05 Hydrogen-Deuterium Exchange (HDX) for Proteins in
Lyophilized Solids
Elizabeth M. Topp, Ph.D., Dane O. Kildsig Chair and Head, Department of Industrial
and Physical Pharmacy, Purdue University
This talk will focus on our group’s recent results using solid-state hydrogen
deuterium exchange with mass spectrometric analysis (ssHDX-MS) for equine
myoglobin (Mb), demonstrating a strong correlation between Mb aggregation
during one year of storage in the solid state and ssHDX-MS results immediately
following lyophilization. ssHDX-MS shows promise as a tool for screening
lyophilized formulations and processing conditions to maintain conformation and
minimize aggregation.
16:35 Rational ADC Formulation Design as aTool to Prevent Chemical
and Physical Instabilities
Janet L. Wolfe, Ph.D., President, Wolfe Laboratories, Inc.
Understanding of the multiple degradation pathways that an ADC can undergo
will enable rational ADC formulation design. Such an approach requires an array
of biophysical and analytical characterization techniques, and yields a de-risked
development path that minimizes the timeline to clinical testing. A case study will
be presented of formulation approaches that mitigate aggregation and chemical
degradation pathways.
17:05 End of Day
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FRIDAY, 6 NOVEMBER
FORMULATION CONSIDERATIONS
FOR EXISTING AND EMERGING BIOMOLECULES
Ajit Narang, Ph.D., Principal Scientist, Drug Product Science and Technology,
Bristol-Myers Squibb
08:35Technical Development Considerations in the Design of
Parenteral Protein Solutions
Ajit Narang, Ph.D., Principal Scientist, Drug Product Science and Technology,
Bristol-Myers Squibb
Emerging data suggests that aggregation instability of a ready-to-use protein
solution drug product may be linked to the shear forces experienced by the
protein during downstream purification. Sustained conformational changes due
to shear during processing may contribute to long-range hydrophobic protein-
protein interactions in protein solutions. These interactions manifest in changes in
the physicochemical properties of proteins including viscosity and hydrodynamic
diameter, in addition to protein aggregation during accelerated stability testing.
09:05 Challenges during Early Stage Formulation Development
Malgorzata Tracka, Ph.D., Scientist II, Formulation Sciences, MedImmune Ltd.
Table 25: Approaches to and Prediction of LongTerm Stability
Moderator: Ernesto Freire, Ph.D., Professor, Biology and Biophysics, Johns
Hopkins University
Table 26: Characterization of ADC Degradation Pathways
Moderator: Janet L. Wolfe, Ph.D., President,, Wolfe Laboratories, Inc.
Table 27: High Concentration Protein Formulations – What AreThe
Limitations of Our Current Analytical Methods?
Moderator: Thomas Hey, Ph.D., Director, Biochemistry, Innovation Center
Complex Formulations, Fresenius Kabi Deutschland GmbH
FORMULATION CONSIDERATIONS FOR EXISTING AND
EMERGING BIOMOLECULES (cont’d)
11:00 Challenges and Strategies for the Accurate Analysis of Protein
Integrity in Sustained Release Depot Formulations
Syed Reza, M.D., Ph.D., Director, Business Development, Octoplus NV
Controlled release microspheres of therapeutic proteins present some special
challenges in pharmaceutical analytical development. Microspheres contain high
weight percentage of polymer which contributes to high background noise and
interference by the polymer component in analysis of protein. Approaches to methods
for protein content, identify, purity and bioactivity will be discussed. Extended duration
microspheres present an added complexity of protein inactivation in situ. Analytical
methods to assess protein integrity during the release phase shall also be presented.
11:30 Protein Conjugates with Hydroxyethylstarch - High Solubility
and Low Viscosity
Thomas Hey, Ph.D., Director, Biochemistry, Innovation Center Complex
Formulations, Fresenius Kabi Deutschland GmbH
HESylation®
- the attachment of the biodegradable and poorly immunogenic polymer
hydroxyethyl starch (HES) to therapeutic proteins - results in an increased efficacy by
stabilization of the protein and prevention of renal excretion.The resulting conjugates
show high solubility, but low viscosity compared to the PEGylated protein, allowing
s.c. administration also of highly concentrated solutions.
12:00Toward Stable Formulations of Peptides: Lessons Learned
Anna-Karin Lundbeck, Ph.D., Formulation Scientist, MedImmune Ltd.
Lunch onYour Own
13:30 Session Break
ADVANCED AND HIGH-THROUGHPUTTECHNIQUES
FOR FORMULATION DEVELOPMENT
Lisa A. Kueltzo, Ph.D., Staff Scientist, Formulation Development, Vaccine
Production Program Laboratory, National Institutes of Health
14:05 Advanced Analysis of Kinetic Stabilities of IgGs Modified by
Mutations and Solvent Additives
Erik Sedlak, Ph.D., Associate Professor, Centre for Interdisciplinary Biosciences and
Department of Biochemistry, P.J. Šafárik University in Košice
The complex thermal transitions of IgGs and their irreversibility pose a challenge
to the proper determination of parameters describing their thermodynamic and
kinetic stability. We present a mathematical model to study the thermal denaturation
of antibodies consisting of three (one reversible and two irreversible) consecutive
transitions.The parameters obtained allowed us to examine the effects of mutations
and solvent additives on the stabilities of individual domains within the full-length IgG.
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14:35 Protein Stabilisation and Formulation Using
Semifluorinated Alkanes
Gesche Graf, Ph.D., Analytical Development Manager, Novaliq GmbH
Semifluorinated Alkanes (SFAs) serve as a well-tolerated alternative drug delivery
medium to water. The SFA platform technology allows formulating APIs as solution
or dispersion which are otherwise unstable or poorly water soluble. Formulating
peptides and proteins with the help of SFAs combines both, the stabilising effect
of the SFAs on peptides and proteins as well as their superior physico-chemical
properties for the use in fields such as ophthalmology.
15:05 Recent Advances in the Prediction of LongTerm Stability of
Biologics Using ICD
Ernesto Freire, Ph.D., Professor, Biology and Biophysics, Johns Hopkins University
New developments have demonstrated that ICD (Isothermal Chemical
Denaturation) is capable of identifying the predominant mode of aggregation of
biologics; quantifying the fraction of the protein that is denatured or aggregated and
also quantifying the total fraction of the protein that is aggregated. These can be
achieved as soon as the protein solution is prepared. The predictive capability of ICD
and its application to formulation optimization will be discussed.
15:35 Comparison of Isothermal andThermal Ramping Approaches to
Vaccine Formulation
Lisa A. Kueltzo, Ph.D., Staff Scientist, Formulation Development, Vaccine Production
Program Laboratory, National Institutes of Health
The use of isothermal methods, such as kD and ICD measurements, has gained
renewed interest.This talk will examine the comparative value of accelerated
temperature methods with alternate isothermal methods, specifically in the
development of low concentration vaccine formulations.The benefits and
disadvantages of the thermal ramping methods such as DSC and DSF techniques will
be reviewed, and the relative predictive ability for real-time stability will be examined.
16:05 Development of a High-Throughput Screening Platform
to Study the Adsorption of Antigens onto Aluminum-Containing
Adjuvants
Vanessa Jully, Ph.D. Student, Université Catholique de Louvain; Advanced Drug
Delivery and Biomaterials, GlaxoSmithKline
We have developed a robust, rapid, and reproducible high-throughput screening
(HTS) platform to study the adsorption capacity of aluminium-containing vaccines.
The adsorption isotherms on aluminum hydroxide and aluminum phosphate of two
model proteins, and two vaccine antigens were evaluated using a liquid handling
system, which permitted rapid sample preparation in a small volume without
nonspecific adsorption. This platform should accelerate data acquisition during the
development of a new vaccine.
WEB PARTNERS
SPONSORING SOCIETIESLEAD SPONSORING PUBLICATIONS
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BIOPRODUCTION & PROTEIN PROCESSING STREAM
Prone to Aggregate
MONDAY, 2 NOVEMBER
AstraZeneca
• High-throughput
• Purity
• Automation
• Protein folding
• Assays
Panelists:
PURIFYING ANTIBODIES
16:35 Magnetically-Driven HybridTechnologies for Antibody Purification
Ana Cecília Afonos Roque, Ph.D., Assistant Professor, Chemistry, UCIBIO,
Faculdade de Ciências e Tecnologia, Universidade Nova de Lisboa
Two magnetically-driven hybrid technologies have been recently proposed by our
group as novel alternatives for non-chromatographic antibody purification. One
approach concerns with the incorporation of magnetic particles into macroporous
structures to confer a magnetic response to the new composites. This magnetic
response was explored for accelerated and efficient protein elution. In a second
approach, the potential to combine aqueous two-phase extraction with magnetic
separation was explored with success.
17:05 Purification of Common-Light-Chain Bispecific Antibodies
Juergen Nett, Ph.D., Associate Director, High Throughput Expression, Adimab LLC
A variety of bispecific constructs benefit from the use of a single variable
light region pairing with multiple distinct variable heavy regions. This talk will
demonstrate new techniques to purify these common-light-chain bispecific IgG
molecules to homogeneity. A panel of bispecific constructs are then generated that
bind to each target with high affinity and exhibit favorable biophysical properties
similar to traditional therapeutic antibodies.
TUESDAY, 3 NOVEMBER
PURIFYING MEMBRANE PROTEINS
MorphoSys AG
08:40 Bacterial Membrane Separation, Fractionation and
Solubilization as Essential Steps in Membrane Protein Purification
We strive to compare and improve different protocols for the fractionation of
proteins from Gram-negative bacteria into outer membrane, cytoplasmic membrane,
periplasmic, and cytosolic fractions. I will compare 5 methods for membrane
fractionation, and will discuss downstream processing and protein purification. I will
also show recent data on fluorescence labeling of different membrane systems, that
we use to track yield and purity of our membrane samples.
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09:10 GPCR Structural Biology: A Case Study with a Novel Fluorescent
Fusion Partner
Saurabh Sen, Ph.D., Principal Scientist, Immune Modulation and NBE Discovery,
Boehringer Ingelheim Pharmaceuticals, Inc.
Structural biology of membrane proteins and GPCRs has seen major advances over
the past few years, but overcoming the challenges of functional GPCR expression and
structural stabilization are still time-consuming and expensive.The talk will focus on
an approach that combines a powerful cloning strategy with novel transmembrane
guides and a novel fluorescent reporter which significantly increases functional
receptor expression in E. coli along with other downstream processing benefits.
Table 7: Bottlenecks in the Purification of Biotherapeutics
Moderator: David O’Connell, Ph.D., Lecturer & Director, MSc Programmes in
Biotherapeutics, Biomolecular & Biomedical Research, University College Dublin
Table 8: Systems for GPCR Expression: HaveWe Identified the BestYet?
Moderator: Saurabh Sen, Ph.D., Principal Scientist, Immune Modulation and
NBE Discovery, Boehringer Ingelheim Pharmaceuticals, Inc.
Table 9:Transition of Projects from Discovery to Development:
What are Important Points to Consider or Lessons Learned?
AFFINITY PURIFICATION
11:20 Recombinant Production and Utilization of Affinity of Proteins
Sophia Hober, Ph.D., Professor, Protein Technology, Biotechnology, KTH Royal
Institute of Technology
Strategies for optimization of protein production and purification will be presented
as well as a miniaturized high throughput method for protein verification. Fusion
tags for improved selectivity of protein purification processes including protein
domains with dual affinity will be presented. The dual affinity design can be of
advantage for protein purification as well as other applications where affinity to
more than one target molecule can be of value. Moreover, a novel, affinity-based
method, that renders site-specific labeling of antibodies possible will be discussed.
11:50 Application of a Novel Fragment Complementation-Based Affinity
System for Improved Protein Purification in a Single Step – from Highly
Soluble to Membrane Proteins andTherapeutic Binder Molecules
In this presentation the performance of a novel EF hand-based fragment
complementation system will be highlighted for the purification of GFP, carbonic
anhydrase, GPCR and DARPin binder proteins. The application of a single-step
purification rationale will be compared to tandem affinity purification approaches
and downstream assays will be described.
Lunch onYour Own
13:20 Session Break
OVERCOMING PURIFICATION CHALLENGES
14:35 Case Studies: IDPs “Intrinsically Disordered Proteins,” Difficult
to Produce, but with a Significant Role in Cellular Pathways
Mario Lebendiker, Ph.D., Head, Protein Purification Facility, Wolfson Centre for Applied
Structural Biology, Institute of Chemistry,The Hebrew University of Jerusalem
Disordered domains in IDPs “Intrinsically disordered proteins” or IDRs “Intrinsically
disordered regions” play a significant role in cellular pathways, with an enormous
potential as medical targets. Because of their lack of stable tertiary structure and
their dynamic interchanging extended and flexible conformations, these types
of proteins are prone to aggregate, and constitute an extraordinary challenge to
produce. We’ll briefly illustrate here our strategy to produce enough amounts of
these type of targets for biophysical and biochemical studies that allows us to show
the way by which such domains act.
15:05 HighYield Expression of Protein Kinases in Insect Cells
Svend Kjaer, Ph.D., Head, Protein Purification, Structural Biology Science Technology
Platform, Francis Crick Institute
Baculovirus mediated infection of insect cells is a well-established technology for
production of proteins with many end-point applications. In this presentation, I’ll
present data on the expression and purification of a kinase target and demonstrate
the importance of co-expression strategies for downstream success. Moreover,
data on a generic method, which significantly improves yields by infection of insect
cell at high cell densities will be presented.
15:35 How to Get the High Hanging Fruits –Tools for Generation of
Difficult-to-Express Antigens
MorphoSys AG
A critical but often unaccounted factor in successful discovery and development of
therapeutic antibodies is the availability of high quality antigens and tool proteins
in sufficient amounts. The presentation will focus on the development of a novel
lysozyme-based expression/purification tag system allowing us to produce difficult-
to-express proteins of high quality as soluble monomers. Diverse case studies on
expression of human CD19, Fc receptors and other proteins will be presented.
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16:05 Native and Stabilized Membrane Proteins for Sponsored by
Drug Discovery
Anass Jawhari, Ph.D., CSO, CALIXAR
CALIXAR has developed patented technology based on new chemistry approach
to safely isolate membrane proteins (GPCR, ion channels, transporters, enzymes
and viral proteins) for drug discovery (antibody development, ligand screening,
SBDD and vaccine application).The presentation will illustrate some case studies
including Adenosine receptor A2A that was solubilized and purified without any single
mutation, truncation or fusion for antibody development purposes and crystallization.
INNOVATING PURIFICATION PROCESSES
17:15 Robust Design of Continuous Purification of AdenovirusVectors by
Two-Column, Simulated Moving-Bed, Size-Exclusion Chromatography
José Paulo Mota, Ph.D., Professor, Chemical and Biochemical Engineering, Animal
Cell Technology, iBET & FCT-Universidade Nova de Lisboa
A two-column simulated moving-bed (2CSMB) process for continuous purification
of adenoviral vectors by size-exclusion chromatography is presented and validated
experimentally, and a general procedure for its robust design under parameter
uncertainty is described. The pilot-scale runs yield a virus recovery of 86% and
impurity clearance of 90% without any fine-tuning of the operating parameters.
This yield is 60% better and the productivity is increased by 6-fold with respect to
single-column batch chromatography for the same volume of resin.
17:45 Estimating Protein Phase Behavior Based on Osmotic Virial
Coefficients – AThermodynamics-Based Approach
Christian Kress, Dipl.-Ing, Scientist, Biochemical and Chemical Engineering,
Laboratory of Thermodynamics, Technical University of Berlin
Currently product capturing within protein production is often based on Protein-A
chromatography, limited in capacity and scalability, which leads to a demand for
different workup strategies (e.g. extraction by ATPS or precipitation). In order to
enable estimations on the applicability of these workup strategies, models to calculate
partition coefficients or protein solubility are required.Therefore a new estimation
strategy based on the second osmotic virial coefficients B22 and B23 is used.
18:15 Purification ofTherapeutic Proteins under Cost Constraints
Stefan Schmidt, Ph.D., Vice President, Process Science & Production, Rentschler
Biotechnologie GmbH
Biologicals and biosimilars represent the fastest growing segment in the drug
pipeline. This puts a lot of pressure on economical manufacturing, primarily solving
efficiency issues in downstream processing. Here I demonstrate how to solve
challenges by applying disposables, using modular concepts, replacing costly
affinity resins and reducing the number of steps in platform processes. The case
studies with examples from various molecule classes highlight successful process
design, optimization strategies and critical manufacturing parameters.
18:45 End of Protein PurificationTechnologies
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Finesse and Control of Bioprocesses
NEXT-GENERATION BIOREACTOR STRATEGIES
Trevor Deeks, Ph.D., QA and QC Consultant, Teva Biopharmaceuticals USA, Inc.
8:35 How Can Measurement, Monitoring, Modeling and Control
Advance Animal Cell Culture in Industrial Biotechnology?
Paula Alves, Ph.D., CEO and Head, Animal Cell Technology, ITQB-UNL,
Instituto de Biologia Experimental e Tecnológica (IBET)
Due to its inherent biological complexity, continued success of animal
cell culture makes the development of measurement, monitoring,
modeling and control methodologies critical both in academic and industrial
environments. Examples of prominent developments include methods for omic
data generation and glycoprotein characterization, tools for real-time monitoring
of cell culture performance, and hybrid modeling approaches to extract process
understanding. This talk will address different cell types and products, identifying
challenges for bioprocess optimization while meeting product quality attributes.
09:20 Large-Scale Production of Phage Antibody Libraries
Using a Bioreactor
Andrew Bradbury, MB, BS, Ph.D., Group Leader and Research Scientist, B Division,
Los Alamos National Laboratory
One limitation of high-throughput phage antibody library selections is the production
of sufficient phage antibody library at the appropriate quality.This talk will describe
the adaptation of a bioreactor-based protocol for the production of phage peptide
libraries to the production of phage antibody libraries.Titers obtained in the stirred-
tank bioreactor are higher than a standard shake flask procedure, and phage antibody
library quality is indistinguishable to that produced using standard procedures.
09:50The Bolt-On Bioreactor Project - Perfusion Bioreactor Design for
Efficient Adherent Cell Culture
Marcos Simón, Ph.D., Founder, Bolt-on Bioreactor Project
Efficiency of bioreactors for the culture of adherent cells lags behind that of their
suspension cells counterparts. The Bolt-on Bioreactor project has studied each
of the four major challenges that preclude adherent cells from becoming the
biopharmaceuticals production system of choice in industry. The result is an efficient
and scalable system for the perfusion culture of adherent cells.
11:30 Miniature BioreactorTechnologies for Rapid Cell Culture Process
Development
Frank Baganz, Ph.D., Senior Lecturer, Biochemical Engineering, University College
London
The need for greater speed during bioprocess development has focused much attention
onto the development and application of miniaturised and high-throughput devices.This
presentation will focus on shaken microwell-based systems and miniature stirred tank
reactors and will cover the engineering characterisation in terms of power input, liquid
phase mixing, and oxygen mass transfer. Examples will be given for the application of
these technologies to rationally scale-up/down cell culture processes.
12:00 Bioengineering Strategies for ex vivo Cultivation and
Purification of Stem Cells
Joaquim M.S. Cabral, Ph.D., Professor and Head, Bioengineering, Instituto Superior
Técnico, University of Lisbon
The development of reliable in vitro systems for stem cell growth is a valuable tool
to study the mechanisms controlling the expansion and differentiation of stem
cells. This lecture presents bioprocess concepts towards the ex vivo expansion of
adult mesenchymal and pluripotent stem cells in bioreactors, while maintaining
their functional characteristics, including the ability to differentiate into appropriate
tissues. Additionally, recent developments are also described and discussed.
Lunch onYour Own
13:30 Session Break
DISPOSABLE BIOREACTORS
Andrew Bradbury, MB, BS, Ph.D., Group Leader and Research Scientist, B Division,
Los Alamos National Laboratory
14:05 Single-Use versus Stainless Steel Bioreactors - Quality Factors
for Consideration When Selecting a Suitable System
Trevor Deeks, Ph.D., QA and QC Consultant, Teva Biopharmaceuticals USA, Inc.
The relative merits of single-use as compared to stainless steel bioreactors has
been widely covered in the literature and in conference presentations. Relative cost,
convenience and capabilities have been the main areas for discussion, but there
has been relatively little debate about quality considerations. Quality considerations
are not often part of the decision-making process to determine the type of system
to select. This presentation discusses these quality factors and how they might
influence the decision.
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14:35 Extractables from Single-Use Bioreactors and Impact on Cell
Culture Performance
Yasser Nashed-Samuel, Ph.D., Principal Scientist, Attribute Sciences, Process
Development, Amgen, Inc.
Biopharmaceuticals are drugs manufactured by growing genetically engineered
cells in bioreactors to produce a therapeutic protein. Plastic single-use bioreactors
are of interest to biopharmaceutical drug manufacturers due to its significant
environmental and cost benefits and flexibility over stainless steel bioreactors.
Effect of plastics on the bio-manufacturing process is not yet completely
understood. A case study on extractables from single-use bioreactors and impact on
cell culture performance will be presented.
15:05 Scaled-Up Manufacturing of Recombinant Antibodies Produced
by Plant or Animal Cells in a 200-L Orbitally Shaken Disposable
Bioreactor
Stefan Schillberg, Ph.D., Head, Molecular Biology, Plant Biotechnology, Fraunhofer
Institute for Molecular Biology
The cultivation of suspended cells in disposable bioreactors for production of
recombinant proteins is a useful alternative to conventional stainless steel stirred-
tank reactors, and orbitally shaken bioreactors could provide further advantages
such as simple bag geometry, scalability and predictable process settings. We
carried out a scale-up study, using a 200-L orbitally shaken bioreactor holding
disposable bags, and plant or animal cells producing human monoclonal antibodies.
Antibodies secreted to the culture medium were purified by affinity chromatography
resulting in high recovery and purity.
SMALL-SCALE MODELING
16:15 Fed-Batch Operation in Small-Scale Bioreactors –
Characterization of a Microtiter Plate-Based Feeding System
Clemens Lattermann, Dipl.-Ing., Scientific Staff, Biochemical Engineering, RWTH
Aachen University
Fed-batch operating conditions in small-scale screening systems are essential for
an efficient bioprocess development. In this work, first an overview about recently
published fed-batch screening systems is given. Furthermore, a novel shaken fed-
batch microtiter plate is presented and characterized. This microtiter plate is based
on substrate diffusion through a hydrogel. A simulation model has been developed,
to better understand the diffusion process and the hydrogel behavior during
substrate diffusion. Finally, the simulation data are compared to experimentally
determined substrate release data.
16:45 Which Outputs of a CFD Simulation Really Affect Process
Performance? - ATwo-Step Scale-Down Approach
Jens Fricke, Ph.D., Project Assistant, Bioprocess Engineering, Environmental
Engineering and Technical Biosciences, Vienna University of Technology
In order to characterize existing processes in homogeneities in large-scale
bioreactors CFD, simulations are usually performed. The questions that remain
are: (1) Which of those gradients actually really affect cell physiology and thereby
process performance? (2) How to anticipate those effects in small-scale in order
to avoid surprises during scale-up? This contribution aims at answering those
questions by proposing a link between the outputs of CFD simulations and the
analysis of its physiological effects in a two-step scale-down approach.
Table 16: Are Our Processes under Control? Can We Rely on the
Monitoring SystemsThat We Use to Provide Sufficient Information
on What is Going on in the Bioreactor?
Moderator: Trevor Deeks, Ph.D., QA and QC Consultant, Teva
Biopharmaceuticals USA, Inc.
Table 17: Integrating Disposable Systems
Table 18: Are the Data We Collect on Processes Sufficiently
Converted to Information? Or Do We Just Store the Data Without
Really UsingThem? What Can Be Improved?
Moderator: Krist Gernaey, Ph.D., Professor, Chemical and Biochemical
Engineering, Technical University of Denmark
19:15 End of Day
THURSDAY, NOVEMBER 5
MODELING & ANALYZING PROCESSES
Joaquim M.S. Cabral, Ph.D., Professor and Head, Bioengineering, Instituto Superior
Técnico, University of Lisbon
08:35 Modeling Bioreactor Dynamics
Matthias Reuss, Ph.D., Professor & Acting Senior Director, Stuttgart Research
Center Systems Biology, University of Stuttgart
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09:05 Multivariate Analysis of Industrial Scale Fermentation Data
Krist Gernaey, Ph.D., Professor, Chemical and Biochemical Engineering, Technical
University of Denmark
Historical process data is available for data mining, and can provide insight into
process operation. Multivariate analysis is a powerful tool for investigating such
large data sets as will be illustrated with an industrial case study. However, there
are also many challenges associated with the application of multivariate analysis
tools to batch process data. This is due to issues related to different batch lengths,
different data sampling intervals, noise in the measurements, and availability of both
online and offline data.
09:35 Rapid Intracellular Nucleoside Phosphate Monitoring in Fed
Batch and Perfusion Cell Cultures using MALDI-TOF-MS
Robert Steinhoff, MSc, Scientist, Chemistry and Applied Biosciences, ETH Zurich
Monitoring intracellular levels of nucleoside phosphates in cell cultures allows
for a very precise determination of cell viability and strongly supports process
development. This interesting metabolite class is accessible using matrix-assisted-
laser desorption/ionization mass spectrometry in combination with a rapid extraction
protocol. The main focus of this talk is dedicated to method development steps and
their application in (i) a hypothermia study in fed batch cultures and (ii) steady-state
investigations in a perfusion cell culture.
INNOVATIVE APPROACHESTO ENSURE QUALITY
11:15 Orbital Shaking –The Next Generation Bioreactor System for
High-Density Animal Cell Culture?
Maria De Jesus, Ph.D., Co-Founder, COO and Vice President, Sciences, ExcellGene SA
Impeller-free mixing of a liquid is possible. However, technical parameters of
shaking processes, such as vessel geometry, direction and frequency of vessel
displacement, gas transfer, power input, shear stress impact, etc. have only
been explored by a few groups. For more than 10 years, we have established
key engineering data and studied the culture performance of orbitally shaken
cylinders from 5 ml to 50 L, to 250 L and eventually to 2500 L. This talk will cover
the essentials of our research and will present surprising data of unpublished case
studies with CHO cells and their performance.
11:45 Free Surface OxygenTransfer in Unbaffled Bio-Reactors
Francesca Scargiali, Ph.D., Assistant Professor, Dipartimento di Ingegneria Chimica,
Gestionale, Informatica e Meccanica, Università degli Studi di Palermo
Animal cell damage in aerated bioreactors is mainly related to the bursting of
bubbles at the air–liquid interface. A viable alternative to sparged bioreactors may be
represented by uncovered unbaffled stirred tanks, which have been found to be able
to provide sufficient mass transfer through the deep free surface vortex which takes
place under agitation conditions so avoiding bubble formation and bursting. Mass
transfer performance of this kind of bioreactor is then presented and discussed.
Lunch onYour Own
13:30 End of Bioreactor Design & Engineering
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Bioproduction: Scaling Up & Down
Modeling to Manufacturing
12:30 Registration
INNOVATING BIOPRODUCTION
Mark Smales, Ph.D., Professor, Biotechnology, Biosciences, University of Kent
13:35 Challenges andTrends Driving Innovation in
Biopharmaceutical Development
Dorothee Ambrosius, Ph.D., SeniorVice President, Global Bioprocess
and Pharmaceutical Development, Boehringer Ingelheim
Biopharmaceuticals GmbH
»»FEATURED PRESENTATION
14:20 Manufacture ofTherapeutic Proteins at the Point-of-Care
Antonio Moreira, Ph.D., Vice Provost for Academic Affairs, Provost’s Office and
Center for Advanced Sensor Technology; Professor, Chemical and Biochemical
Engineering, University of Maryland
Our team has been developing a compact, agile platform designed to produce
therapeutic proteins at the point-of-care. In this presentation, we will describe our
progress towards making a briefcase sized device that will serve as the factory of
the future, and enable biologics production on-demand at the point-of-care. Our
core technology uses a novel CHO cell extract for in vitro expression of virtually any
protein and couples it with a simple, single step intein-based purification system
that has the potential of producing a therapeutic ready for delivery to the patient.
STRATEGIES FOR ANTIBODY PRODUCTION
16:05 From Bench to GMP, Develop Quick and Clean ADC Processes
Eric LaCoste, Ph.D., ADC Team Leader, Chemistry & Biotechnology Development,
Sanofi-Aventis Research & Development
How to go Quick and Clean from bench to GMP? How to deal with project constraints?
The Sanofi’s ADC team develops processes in QbD-oriented strategies to rapidly deliver
a scalable process contributing to process and product knowledge. Selected examples
on conjugation reaction and purification development will be presented.
16:35 Bispecific Antibodies from Engineering to Optimized In-House
Phase I Manufacturing
Stanislas Blein, Ph.D., Senior Director and Head, Antibody Engineering, Biologics
Research, Glenmark Pharmaceuticals S.A.
Glenmark Pharmaceutical`s BEAT® platform is a novel bispecific heavy chain hetero-
dimerization platform based on a unique concept of bio-mimicry. We have produced
several T cell recruiting bispecific antibodies against different cancers. Our most
advanced program GBR 1302 potently re-directs T cells to HER2 positive cancer
cells demonstrating strong tumour cell lysis activity with an excellent safety-efficacy
window. Preclinical data and manufacturing process will be presented.
17:05 End of Day
FRIDAY, 6 NOVEMBER
SCALING UP & DOWN
Alan G. Ryder, Ph.D., Senior Lecturer, Nanoscale Biophotonics Laboratory, School of
Chemistry, National University of Ireland, Galway
08:35 Scale-Down Models Enable Identification of microRNAs to
Enhance Cellular Performance of Mammalian Cell Factories
Kerstin Otte, Ph.D., Professor, Molecular Biology and Gene Technology,
Pharmaceutical Biotechnology, University of Applied Sciences Biberach
Mammalian expression systems still exhibit bottlenecks during protein production
invoking efforts to improve production capacity of host cells. The development
of novel engineering strategies is usually performed in small scale formats. We
will present a small scale, high-throughput functional screen using microRNAs to
optimize production in CHO cells revealing vast numbers of microRNAs to improve
production performance. An entire miRNA family is shown to exhibit pro-productive
properties transferable from small scale to larger scale formats.
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09:05 Challenges in Scale-Up of Cell Culture Processes from Lab Scale
to Full Commercial
Christian Sieblist, Ph.D., Manager, Science and Engineering Lab, Roche Pharma
Biotech Production, Roche Diagnostics GmbH
Table 28:The Benefits and Business Case for More Standardization
and Automation in Biopharma
Moderator: Moritz von Stosch, Ph.D., Lecturer, Chemical Engineering and
Advanced Materials, Science, Agriculture and Engineering, Newcastle
University; CEO, HybPAT Technologies
Table 29:The Relevance of Integrated Bioprocess Development
Table 30: ProcessTransfer and Manufacturing at CMOs
ENHANCING PRODUCTIVITY
11:00 Impact of Large-Scale Bioreactor Heterogeneities on
Transcriptional and Metabolic Regulation in Industrial Producers
Ralf Takors, Ph.D., Director, Biochemical Engineering, University of Stuttgart
E. coli is commonly used for recombinant protein production in lab and in production
scale. When cells are exposed to large scale production conditions, they face
frequently varying micro-environmental conditions due to insufficient mixing and
spatial heterogeneities.This contribution shows impacts of large scale heterogeneities
mirrored on the metabolic and transcriptional levels of E. coli that finally serve to
optimize bioreactor design and the genomic platform of the producer cell.
11:30 CHO Cell Line Engineering – Protein Quantification on the
Octet RED96
Stefan Kol, Ph.D., Protein Biochemist, CHO Cell Line Engineering Core Facility, Novo
Nordisk Foundation Center for Biosustainability, Technical University of Denmark
Erythropoietin (EPO) quantification during cell line selection and bioreactor
cultivation has traditionally been performed with ELISA or HPLC. As these
techniques suffer from several drawbacks, we developed a novel EPO quantification
assay. A camelid single-domain antibody fragment (VHH) directed against human
EPO was evaluated as a capturing antibody in a label-free biolayer interferometry-
based quantification assay. Human recombinant EPO can be specifically detected
in Chinese hamster ovary cell supernatants in a sensitive and pH-dependent
manner. This method enables rapid and robust quantification of EPO in a
high-throughput setting.
12:00 Determination of Recombinant Mammalian Cell Line Phenotypes in
the Bioreactor at the 96-DeepWell Plate Scale during Cell Line Development
Using Intact MALDI-ToF Mass Spectrometry and PLS-DA Modeling
Here we described the application of an intact cell MALDI-ToF mass spectrometry
fingerprinting method coupled with mathematical modeling to the cell line construction
process for the prediction and isolation of high producing cell lines. We show how
MALDI-ToF mass spectrometry data of cell lines gathered at the 96 deep well plate
stage of cell line construction can be used to predict the phenotype of mammalian cell
lines at the 10 L fermenter scale using a Partial Least Squares Discriminant Analysis
(PLS-DA) model.The modeling approach provides the basis for the early prediction of
cell line performance in cGMP manufacturing-scale bioreactors. We will discuss the
possibility of extending the application to product quality attributes.
Lunch onYour Own
13:30 Session Break
SINGLE-USE, MONITORING QUALITY & PROCESS
EXCELLENCE STRATEGIES
14:05 Case Study: Scale-Up of an Allogeneic CellTherapy Product
Using Single-Use Systems
Ravinder Bhatia, MSc, Scientific Director, PDMS/API-LM, Janssen Research &
Development
One of the major challenges with cell therapy products is the development
of a robust and scalable process to produce the product for clinical trials and
commercialization. Currently, numerous technologies are available for the scale-
up of an allogeneic cell therapy product in static (e.g. T-flasks and cell factories) or
suspension (e.g. microcarriers, bioreactor type) cultures. In this presentation, a
case study will be presented on process development and scale-up of an allogeneic
human somatic cell therapy product using single-use technologies.
14:35 Combining Multi-Dimensional Fluorescence Spectroscopy and
Chemometric Analysis for Quantitative Bioprocess Monitoring
Multi-dimensional fluorescence spectroscopy (MDFS) was used for quantitative
predictive analysis of glycoprotein production and content in CHO cell fed-batch
process. MDFS spectra of complex solutions were sensitive to compositional
change and as cultivation progressed, amino acid, and glycoprotein product
emission varied as the chemical composition changed and culture progress could be
monitored quantitatively using a variety of multivariate analysis techniques. In one
case, unique dityrosine emission from product glycoprotein could be used to follow
product formation. The MDFS variance could also be used to generate quantitative
predictive models of process performance based on glycoprotein yield.
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15:05 Using Different QbDTools to Support Scale-Down and Scale-Up
of Bioprocesses: Examples from Small and Large Molecules
Jose C. Menezes, Ph.D., Professor, Bioengineering and Biosciences, Technical
University of Lisbon
The use of disciplines from the QbD (Quality by Design) tool box will be
demonstrated to support science-based bioprocess industrialization and
manufacturing (e.g., design-spaces, multivariate end-point and batch trajectory
control). Scale-up with PAT tools and/or validated scale-down models for DoE
and troubleshooting will be highlighted for small and large molecules. Process
performance and product quality will be considered in these approaches.
15:35 Monoliths as PATTools for Bioprocess Improvement
Oliver Spadiut, Ph.D., Group Leader, Integrated Bioprocess Development,
Biochemical Engineering, Vienna University of Technology
Monolithic columns are a special type of chromatography column which can be
used for the purification of different biomolecules. They have become popular due to
their high mass transfer properties and short purification times. However, they also
describe powerful PAT tools for bioprocess monitoring and development. I will show
how monoliths can be used as efficient impurity monitoring tools during bioreactor
cultivations but also across unit operations for recombinant protein production
processes with yeast.
16:05 Hybrid Modeling as a QbDTool for PAT in Biopharma
Moritz von Stosch, Ph.D., Lecturer, Chemical Engineering and Advanced Materials,
Science, Agriculture and Engineering, Newcastle University; CEO, HybPAT
Technologies
Process understanding is at the heart of the PAT initiative and QbD paradigm.
The integration of Risk Analysis, Design of Experiments and Multivariate
Data Analysis (MVDA) is the predominantly applied approach in biopharma to
understand processes, nowadays. In this talk, it will be shown that the integration
of fundamental process knowledge along with MVDA into hybrid models has the
potential to improve the prediction performance, reduce the experimental effort and
support the knowledge exchange between scales.
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PROTEIN EXPRESSION STREAM
2-3 November 2015 | EIGHTH ANNUAL
Genes, Codons, Vectors and Clones
MONDAY, 2 NOVEMBER
AstraZeneca
• High-throughput
• Purity
• Automation
• Protein folding
• Assays
Panelists:
VECTOR ENGINEERING
Kirill Alexandrov, Ph.D., Professor, Institute for Molecular Bioscience, Australian
Institute of Bioengineering and Nanotechnology, University of Queensland
16:35 A Synthetic Optimised Vector System for Chlamydomonas
reinhardtii
Kyle J. Lauersen, Ph.D., Faculty of Biology, Algae Biotechnology & Bioenergy,
Center for Biotechnology, Bielefeld University
Microalgae are interesting hosts for numerous natural products and hold the
capacity for light-driven photo-bioproduction. However, complicated genetics
and limited molecular tools have hindered significant development in transgenic
algal technologies that could further their biotechnological potential. This work
presents the development of a modular versatile vector for the model microalgae
Chlamydomonas reinhardtii. This system serves as a standardised platform for
future genetic engineering of this valuable algal species.
17:05 In vitro Reconstitution and Analysis of Protein Interaction
Networks
Kirill Alexandrov, Ph.D., Professor, Institute for Molecular Bioscience, Australian
Institute of Bioengineering and Nanotechnology, University of Queensland
The exponential increase sequenced genomes has focused attention on how best
to produce, study and modify the encoded gene products. We created a suite of
in vitro expression Gateway vectors that allow us to rapidly express genes from
human ORFeome libraries in Leishmania tarentolae cell-free system. We combine
single molecule fluorescence spectroscopy and Amplified Luminescent Proximity
Homogeneous Assay Screen to analyse the interactions of subunits of several in
vitro reconstituted multisubunit eukaryotic protein complexes.
TUESDAY, 3 NOVEMBER
GENE ENGINEERING
Helene Faustrup Kildegaard, Ph.D., Co-Principal Investigator, Novo Nordisk
Foundation Center for Biosustainability, Technical University of Denmark
Prone to Aggregate
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08:40Tailoring CHO Cell Metabolism via MicroRNA Manipulation to
Boost Recombinant Protein Productivity
Niall Barron, Ph.D., Program Leader, Mammalian Cell Engineering, National Institute
for Cellular Biotechnology, Dublin City University
MicroRNA engineering has already proved successful in enhancing various CHO cell
phenotypes relevant to production of recombinant products. miR-23 has previously
been demonstrated to play a role in glutamate metabolism providing an alternative
source of critical metabolites for the TCA cycle, ultimately strengthening oxidative
metabolism. We consider how reprogramming cellular bioenergetics through
miR-23 may allow mammalian production cells to be more productive by favouring
metabolic channeling into oxidative metabolism.
09:10 Bicistronic mRNAs to Enhance Membrane Protein
Overexpression
Jacopo Marino, Ph.D., Research Scientist, Chemistry and Biochemistry, Gene
Center, University of Munich
We present an approach for improving the functional overexpression of membrane
proteins in Escherichia coli using transcriptional fusions. The method involves the
use of a small additional RNA sequence upstream to the RNA sequence of the
target membrane protein and results in the production of a bicistronic mRNA.
Transcriptional fusions do not require protease treatment and subsequent removal
of the fusion protein.
Table 11: CRISPR/Cas9-Mediated Cell Factory Engineering:
Opportunities and Challenges
Moderator: Helene Faustrup Kildegaard, Ph.D., Co-Principal Investigator, Novo
Table 12: Integrative Approaches for Improving Heterologous
Membrane Protein Expression in E. coli
Moderator: Jacopo Marino, Ph.D., Research Scientist, Chemistry and
Biochemistry, Gene Center, University of Munich
GENE ENGINEERING (CONT’D)
11:20 Improved CHO Cell Factories Using CRISPR Cas9 Genome
EditingTechnologies
Helene Faustrup Kildegaard, Ph.D., Co-Principal Investigator, Novo Nordisk
Foundation Center for Biosustainability, Technical University of Denmark
The high efficiency of the CRISPR Cas9 genome editing technology has enabled
fast and easy construction of engineered cell lines. Here, our efforts on generating
precise gene disruptions and gene insertions using CRISPR Cas9 will be presented
together with a fast and high-throughput platform for constructing CRISPR Cas9
reagents. In addition, examples of improved CHO cell factories generated using
these technologies will be presented.
11:50 Inactivation of GDP-FucoseTransporter Gene (Slc35c1) in CHO
Cells by ZFNs,TALENs and CRISPR-Cas9 for the Production of Fucose-
Free Antibodies
Bioprocessing Technology Institute, A*STAR
GDP-fucose transporter gene (Slc35c1) in CHO-K1 cells was inactivated by ZFNs,
TALENs and CRISPRs for the production of fucose-free antibodies. The Slc35c1
gene was also inactivated in a pre-existing antibody-producing CHO line that
produces the anti-Her2 antibody. Inactivation of the GDP-fucose transporter did not
affect cell growth or antibody productivity.
Lunch onYour Own
13:20 Session Break
ENGINEERING HIGHER EXPRESSION
Diethard Mattanovich, Ph.D., Professor, Microbial Cell Design, University of Natural
Resources and Life Sciences, Vienna and Director, Area Systems Biotechnology and
Microbial Cell Engineering, Austrian Centre of Biotechnology
14:35 Streamlining the Expression Screening of Membrane Proteins
Ray Owens, Ph.D., Head, Oxford Protein Production Facility-UK, Research Complex
at Harwell and Professor, Molecular Biology, University of Oxford
The production of recombinant membrane proteins for structural and functional
studies remains technically challenging due to low levels of expression and the
inherent instability of many membrane proteins once solubilised in detergents. One
approach to overcoming these issues is to evaluate multiple membrane protein/
variants. Combining ligation independent cloning of membrane proteins as GFP
fusions with expression detected by GFP fluorescence enables this to be carried
out rapidly and efficiently.
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15:05Tiny but Mighty – Functional High-Content MicroRNA Screening
Provides aVersatileToolbox for Next-Generation CHO Cell Engineering
MicroRNAs constitute an important class of non-coding RNAs in mammals.
Individual miRNAs control entire cellular pathways without adding translational
burden to cells and thus have received growing attention in biotechnology. A
functional high-content miRNA screening in CHO cells discovered hundreds
of miRNAs to substantially improve bioprocess relevant cell functions. Our
comprehensive miRNA research led to the generation of a “miRNA target catalog”
providing an avenue for next-generation CHO cell engineering.
15:35 Construct Engineering Provides a Platform for High-Quality
GPCR Generation
Oliver Schlenker, Ph.D., Senior Research Scientist, Protein Engineering, Heptares
Therapeutics
Protein engineering allows achieving high-quality protein from difficult-to-tackle G
protein-coupled receptors (GPCRs). Our stabilised receptors (StaRs) enable us to
express and purify material suitable for biophysical characterisation. Optimisation of
protein termini and utilisation of fusion proteins result in significant improvements in
expression, quality and crystallisation. We provide a powerful solution for high-end
quality protein delivery to find drug candidates for diseases such as Alzheimer’s
and diabetes.
ENGINEERING HIGHER EXPRESSION (CONT’D)
17:15 Metabolic Engineering of NADPH Supply Enhances
Recombinant Protein Production in Pichia pastoris
Diethard Mattanovich, Ph.D., Professor, Microbial Cell Design, University of Natural
Resources and Life Sciences, Vienna and Director, Area Systems Biotechnology and
Microbial Cell Engineering, Austrian Centre of Biotechnology
Based on a genome-scale metabolic model of the yeast Pichia pastoris we
predicted gene knockouts and gene overexpressions in the central metabolism to
improve recombinant protein production. Experimental validation showed that the
best effect was achieved by enhancing the pentose phosphate pathway, which is
the major supplier of reduced NADPH. The optimum metabolic interventions will be
discussed based on detailed analysis of gene regulation and metabolic fluxes.
17:45 Enhanced Protein Production byTransientTransfection of
HEK293 by Extended Gene Expression
Francesc Gòdia, Ph.D., Professor, Chemical Engineering, Universitat Autònoma de
Barcelona
Extended gene expression (EGE) is a strategy proposed to prolong the production
period of recombinant proteins by HEK293 cells transient transfection by repeatedly
transecting cell cultures, together with performing a medium exchange. The
benefits of this method are discussed for the production of three model products
including two recombinant proteins (intracellular and secreted GFP) and a complex
VLP (Gag-based VLPs).
Enabling Protein Expression through Intelligently Engineered
Platforms
Technical challenges for accelerating recombinant protein production persist from
genes to vectors to constructs to clones, and these multiple variables are required
when developing reliable expression systems. This panel gathers experts to debate
the benefits and tradeoffs of traditional and novel engineering strategies that lead to
greater, faster high-quality biotherapeutics.
Moderator: Diethard Mattanovich, Ph.D., Professor, Microbial Cell Design, University
of Natural Resources and Life Sciences, Vienna and Director, Area Systems
Biotechnology and Microbial Cell Engineering, Austrian Centre of Biotechnology
Panelists:
Niall Barron, Ph.D., Program Leader, Mammalian Cell Engineering, National Institute
for Cellular Biotechnology, Dublin City University
Francesc Gòdia, Ph.D., Professor, Chemical Engineering, Universitat Autònoma de
Barcelona
Ray Owens, Ph.D., Head, Oxford Protein Production Facility-UK, Research Complex
at Harwell and Professor, Molecular Biology, University of Oxford
Oliver Schlenker, Ph.D., Senior Research Scientist, Protein Engineering, Heptares
Therapeutics
18:45 End of Engineering Expression Systems
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Meeting the Demand for Recombinant Proteins
Prone to Aggregate
CELL LINE DEVELOPMENT
Bioprocessing Technology Institute, A*STAR
08:35 Alternative Cell Line Development:The Use of Polycistronic
Vectors and Alternate-Splicing for Multimeric Protein Expression
Pierre Moretti, Ph.D., Head, Cell Line Development, Glenmark
Pharmaceuticals
This talk introduces the alternate splicing-based multicistronic vectors
developed at Glenmark for the expression of multimeric protein such
as bispecific antibodies.
09:20 Boosting Antibody Cell Line Performance without
Compromising the Desired Glycan Composition
Volker Sandig, M.D., Ph.D., CSO, ProBioGen
An optimal and consistent glycan pattern is desired for novel antibodies while
reproduction of the original pattern is critical for biosimilar development. When
selecting the final clone, posttranslational modifications may get in conflict with
process performance and maximal titer. An advanced flexible vector platform and
control of complex N-Glycans (including fucosylation, galactosylation and sialylation)
with heterologous enzymes, glycan precursors and microelements support the
perfect choice for each antibody.
09:50 A Quick and Efficient Method to Generate Mammalian Stable
Cell Lines Based on a Novel Inducible Alphavirus DNA/RNA
Layered System
Alejandro Aranda, Ph.D., Principal Investigator, Vectors Development Lab, END-ICAP
Unit, INSERM, University of Versailles – Saint Quentin en Yvelines
We report a new method to generate high-expressing mammalian cell lines in a
quick and efficient way. For that purpose, we developed a master cell line (MCL)
containing an inducible alphavirus vector expressing GFP integrated into the
genome. New cell lines can be generated based on MCL by recombinase mediated
cassette exchange, leading to quick generation of inducible cell lines expressing
proteins of therapeutic interest.
10:20 Platform Expression Systems for Rapid Sponsored by
Development of Microbial & Mammalian Cell Lines for
Biopharmaceutical Production
Ian Hodgson, Ph.D., BSc, Head, Molecular Biology, FUJIFILM
Diosynth Biotechnologies
The process development of biopharmaceuticals demands concise timelines (to
get products into clinic quickly), high product titres (with correct product quality),
coupled with the ability to use the same expression system throughout the product
life cycle. We have developed platform approaches to cell line development for both
bacterial and mammalian expression, which combine all of these attributes. We will
describe the development of these systems, and show data that demonstrates
their performance.
11:30 Expression and Cell Line Development of Complex and Fc-
ModifiedTherapeutic Antibodies
Johannes Auer, Ph.D., Principal Scientist, Large Molecule Research, Roche Pharma
Research & Development, Roche Innovation Center Penzberg
The process of generating complex therapeutic antibodies from first test
expressions until the selection of cell clones for the primary seed bank will be
described. Exemplified insights will be presented into how we determine individual
characteristics of a given molecule, how we balance quantity and quality of the
product and how we deal with proof of monoclonality of cell clones and their stable
productivity for clinical supply.
12:00 Generation ofTagged Mammalian Cell Lines with an Improved
Recombinase Exchangeable Cassette
Johannes Spehr, Ph.D., Research Scientist, Recombinant Protein Expression,
Helmholtz Centre for Infection Research
Recombinase mediated cassette exchange (RMCE) is a fast and reliable technique
to stably integrate a gene-of-interest into a well-characterized master cell line.
By using the trifunctional selective marker Hygromycinephosphotransferase-
Thymidinkinase-eGFP (HTG) we improved and accelerated the generation of new
producer cell lines for high expression. The HTG combines positive selection for
Hygromycin and eGFP during master cell line generation with negative selection on
Ganciclovir during cassette exchange.
12:30 Rapid Production of Recombinant Proteins Sponsored by
and Stable Cell Lines
Peer Heine, Ph.D., Field Application Scientist, MaxCyte, Inc.
Success means getting to market fast. Therefore, fast and efficient protein
production for drug candidate development, characterization, and selection is
critical. Creating a stable cell line for clinic trial, takes months to more than a year
for complicated proteins. High efficiency, scalable electroporation can reduce stable
cell line development timelines by up to 50%, even in difficult-to-transfect cell lines.
In this presentation, data will show the rapid production of proteins and cell lines at
different scales.
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Lunch onYour Own
13:30 Session Break
CONSTRUCTING HIGH PRODUCERS
THROUGH GENOME ENGINEERING
Cecília Calado, Ph.D., Professor, Chemical Engineering Department, ISEL-Instituto
Superior de Engenharia de Lisboa, Instituto Politécnico de Lisboa
14:05 Sequencing the CHO DXB11 Genome Reveals Regional
Variations in Genomic Stability and Haploidy
Christian Schrøder Kaas, Research Scientist, Mammalian Cell Technology, Novo
Nordisk A/S
The copy number from each gene in the genome was calculated from next-
generation sequencing data and revealed an unexpected degree of haploidy in
Chinese Hamster Ovary (CHO) cells. The data can further be mined to reveal areas
of the genome shown to be stable, such as chromosomes one and four, which can
be hypothesised to host favourable landing platforms for targeted integration of
transgenes encoding coagulation factors or antibodies.
14:35Tunable Gene Expression Control of the RiboTite System
Neil Dixon, Ph.D., MRSC, BBSRC David Phillips Research Fellow, Manchester
Institute of Biotechnology, Faculty of Life Sciences, University of Manchester
Here we report the development and application a novel recombinant E. coli
expression system that operates at translational level. The RiboTite system has
been benchmarked against classical gene expression control mechanisms for
the production of various reporter and target proteins of clinical importance. The
system permits tunable cellular level regulation, tight basal control, high levels of
expression upon induction, and predictable specific production rates across a range
of growth temperatures.
15:05 Minimally Invasive Host Cell Design and Growth Decoupled
Protein Production - New Concepts to Further Advance E. coli
Expression Systems
Gerald Striedner, Ph.D., Assistant Professor, Biotechnology, University of Natural
Resources and Life Sciences
Our E. coli expression system design is strongly focused on making them fit
for production conditions. One strategy to improve fitness and performance of
production cells is the reduction of the recombinant infrastructure to essential
compounds to minimise metabolic load and cell response to recombinant gene
expression. An alternative concept is based on decoupling cell growth and
product formation to allocate cells’ full protein synthesis capacity to recombinant
protein production.
CONSTRUCTING HIGH PRODUCERS
THROUGH BIOPROCESS
16:15 Presentation to be Announced
16:45 In situ Near-Infrared versus High-Throughput Mid-Infrared
Spectroscopy to Monitor Biopharmaceuticals Production
Cecília Calado, Ph.D., Professor, Chemical Engineering Department, ISEL-Instituto
Superior de Engenharia de Lisboa, Instituto Politécnico de Lisboa
Global regulatory agencies impose stringent quality guidelines concerning
biopharmaceutical production that have been changing to meet the Quality by
Design (QbD) framework. Highly sensitive analytical techniques, as the ones based
on Fourier Transformed Infra-Red (FTIR) spectroscopy enabling simultaneous
characterisation of heterologous product synthesis and physiologic cell behavior,
are therefore desirable. We compare in situ near-FTIR versus high-throughput Mid-
FTIR spectroscopy concerning monitoring of critical process variables and general
cell physiology.
Table 19: Opportunities and Challenges of Bacterial Production
Strain Engineering Using Synthetic Biology
Moderator: Neil Dixon, Ph.D., MRSC, BBSRC David Phillips Research Fellow,
Manchester Institute of Biotechnology, Faculty of Life Sciences, University of
Manchester
Table 20: Protein Glycosylation: Challenges and Opportunities for
the Biotech Industry
Moderator: Zhiwei Song, Ph.D., Principal Scientist, Lead PI for GlycoSing
Programme, Bioprocessing Technology Institute, A*STAR
19:15 End of Day
CASE STUDIES: UPSTREAM DECISIONS LEADTO
DOWNSTREAM SUCCESSES
Georg Klima, Executive Director, Process Science Austria, Biopharmaceuticals
Division, Boehringer Ingelheim RCV
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08:35 From Bench to Clinic – FastTrack Process Development for
Novel Biotherapeutics in Microbial Expression Systems
Georg Klima, Executive Director, Process Science Austria, Biopharmaceuticals
Division, Boehringer Ingelheim RCV
Novel biotherapeutic formats pose unique development challenges as established
platform processes are rarely applicable. To achieve rapid assessment of novel
constructs’ safety in nonclinical and clinical testing, alternative process development
strategies are required. A versatile toolbox approach utilising E. coli and Pichia
pastoris expression systems and automated high-throughput process development
will be presented. Further, we highlight a systematic approach for robust scale-up
and transfer from bench to clinical scale manufacturing.
09:05 Eukaryotic Lysates for Cell-Free Bioproduction
Marlitt Stech, Ph.D., Research Scientist, Cell-Free Bioproduction, Fraunhofer
Institute for Cell Therapy and Immunology (IZI), Branch Bioanalytics and
Bioprocesses Potsdam-Golm (IZI-BB)
We introduce novel systems for the cell-free production of glycoproteins,
membrane proteins and functional antibody fragments in an endotoxin-free
environment. The eukaryotic translation systems developed are based on
translationally active lysates from cultured Sf21 and CHO cells which contain
endogenous microsomal vesicles. The presence of these microsomes enables a co-
translational translocation of target proteins, improved conditions for protein folding
and enrichment and their subsequent posttranslational modification.
09:35 Development of Quasi-Continuous Recombinant Protein
Production with MVDA Golden Batch Evaluation, Prediction and Control
Sven-Oliver Borchert, Research Fellow, Research Center of Bioprocess Engineering
and Analytical Techniques, Hamburg University of Applied Sciences
We present a case study describing the development and optimisation of an
integrated plant for quasi-continuous production of a pharmaceutical protein with
Pichia pastoris. Development steps follow the principles of Quality by Design
(QbD), Process Analytical Technology (PAT) and Design of Experiments (DoE).
The production and optimisation strategy will be illustrated by the device-related
integrated plant approach and thoroughly automated upstream and downstream
processing with Golden Batch process monitoring and control.
10:05 cGMP Biologics Production Using Corynex® : Sponsored by
A Highly-Productive Gram-Positive Microbial Protein
Secretion System
Yoshimi Kikuchi, Ph.D., Principal Researcher, Ajinomoto Co., Inc.
Corynex® is Ajinomoto’s highly productive protein expression system based on
the gram-positive bacteria C. glutamicum. The easy-to-handle platform can secrete
correctly-folded proteins directly into media with high purity, free from cell lysis,
refolding, endotoxins, and spores. We recently demonstrated successful 1000L
GMP biologics production using Corynex®.
CASE STUDIES: UPSTREAM DECISIONS LEADTO
DOWNSTREAM SUCCESSES (CONT’D)
11:15The Incorporation of Non-Natural Amino Acids Enables
Empowered Antibodies for CancerTherapy
Gang Yin, Ph.D., Principal Scientist, Protein Biochemistry, Sutro Biopharma, Inc.
A cell-free protein synthesis system was engineered for site-specific incorporation
of non-natural amino acids (nnAAs). Methods have been developed for conjugation
of synthetic molecules to antibodies or antibody to antibody by Azide/DBCO or
Tetrazine/Trans-cyclooctenes reaction at desired sites. Incorporation of non-natural
amino acids and development of conjugation chemistries enable empowered
antibodies for cancer therapy. Three applications were discussed: antibody drug
conjugates with single warhead and combination warheads, bispecific antibodies,
and extended half-life antibodies by pegylation.
11:45 Wacker Biotech RefoldingTechnology –The
Complement to our ESETEC® Secretion Platform
Guido Seidel, Ph.D., Managing Director, Operations, Wacker Biotech GmbH
Wacker Biotech is known as THE MICROBIOAL CMO. We lead the development
of innovative, cost-saving E. coli technologies for recombinant manufacturing
of biopharmaceuticals. Depending on customers need we can produce difficult
to expressed proteins via E. coli Secretion Technology - ESETEC® or with our
proprietary refolding technology.
Lunch onYour Own
13:30 End of Applying Expression Platforms
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INNOVATING BIOPRODUCTION
13:35 Challenges andTrends Driving Innovation in
Biopharmaceutical Development
Dorothee Ambrosius, Ph.D., Senior Vice President, Global
Bioprocess and Pharmaceutical Development, Boehringer
Ingelheim Biopharmaceuticals GmbH
14:20 Manufacture ofTherapeutic Proteins at the Point-of-Care
Antonio Moreira, Ph.D., Vice Provost for Academic Affairs, Provost’s Office and
Center for Advanced Sensor Technology; Professor, Chemical and Biochemical
Engineering, University of Maryland
Our team has been developing a compact, agile platform designed to produce
therapeutic proteins at the point-of-care. In this presentation, we will describe our
progress towards making a briefcase sized device that will serve as the factory of
the future, and enable biologics production on-demand at the point-of-care. Our
core technology uses a novel CHO cell extract for in vitro expression of virtually any
protein and couples it with a simple, single step intein-based purification system
that has the potential of producing a therapeutic ready for delivery to the patient.
STRATEGIES FOR ANTIBODY PRODUCTION
16:05 From Bench to GMP, Develop Quick and Clean ADC Processes
Eric LaCoste, Ph.D., ADC Team Leader, Chemistry & Biotechnology Development,
Sanofi-Aventis Research & Development
How to go Quick and Clean from bench to GMP? How to deal with project
constraints? The Sanofi’s ADC team develops processes in QbD-oriented strategies
to rapidly deliver a scalable process contributing to process and product knowledge.
Selected examples on conjugation reaction and purification development will
be presented.
16:35 Bispecific Antibodies from Engineering to Optimized In-House
Phase I Manufacturing
Stanislas Blein, Ph.D., Senior Director and Head, Antibody Engineering, Biologics
Research, Glenmark Pharmaceuticals S.A.
Glenmark Pharmaceutical`s BEAT®
platform is a novel bispecific heavy chain hetero-
dimerization platform based on a unique concept of bio-mimicry. We have produced
several T cell recruiting bispecific antibodies against different cancers. Our most
advanced program GBR 1302 potently re-directs T cells to HER2 positive cancer
cells demonstrating strong tumour cell lysis activity with an excellent safety-efficacy
window. Preclinical data and manufacturing process will be presented.
17:05 End of Day
FRIDAY, 6 NOVEMBER
SCALING UP & DOWN
08:35 Scale-Down Models Enable Identification of microRNAs to
Enhance Cellular Performance of Mammalian Cell Factories
Kerstin Otte, Ph.D., Professor, Molecular Biology and Gene Technology,
Pharmaceutical Biotechnology, University of Applied Sciences Biberach
Mammalian expression systems still exhibit bottlenecks during protein production
invoking efforts to improve production capacity of host cells. The development
of novel engineering strategies is usually performed in small scale formats. We
will present a small scale, high-throughput functional screen using microRNAs to
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optimize production in CHO cells revealing vast numbers of microRNAs to improve
production performance. An entire miRNA family is shown to exhibit pro-productive
properties transferable from small scale to larger scale formats.
09:05 Challenges in Scale-Up of Cell Culture Processes from Lab Scale
to Full Commercial
Christian Sieblist, Ph.D., Manager, Science and Engineering Lab, Roche Pharma
Biotech Production, Roche Diagnostics GmbH
Table 28:The Benefits and Business Case for More Standardization
and Automation in Biopharma
Moderator: Moritz von Stosch, Ph.D., Lecturer, Chemical Engineering and
Advanced Materials, Science, Agriculture and Engineering, Newcastle
University; CEO, HybPAT Technologies
Table 29:The Relevance of Integrated Bioprocess Development
Table 30: ProcessTransfer and Manufacturing at CMOs
ENHANCING PRODUCTIVITY
11:00 Impact of Large-Scale Bioreactor Heterogeneities on
Transcriptional and Metabolic Regulation in Industrial Producers
E. coli is commonly used for recombinant protein production in lab and in
production scale. When cells are exposed to large scale production conditions,
they face frequently varying micro-environmental conditions due to insufficient
mixing and spatial heterogeneities. This contribution shows impacts of large scale
heterogeneities mirrored on the metabolic and transcriptional levels of E. coli
that finally serve to optimize bioreactor design and the genomic platform of the
producer cell.
11:30 CHO Cell Line Engineering – Protein Quantification on the
Octet RED96
Stefan Kol, Ph.D., Protein Biochemist, CHO Cell Line Engineering Core Facility, Novo
Erythropoietin (EPO) quantification during cell line selection and bioreactor
cultivation has traditionally been performed with ELISA or HPLC. As these
techniques suffer from several drawbacks, we developed a novel EPO quantification
assay. A camelid single-domain antibody fragment (VHH) directed against human
EPO was evaluated as a capturing antibody in a label-free biolayer interferometry-
based quantification assay. Human recombinant EPO can be specifically detected
in Chinese hamster ovary cell supernatants in a sensitive and pH-dependent
manner. This method enables rapid and robust quantification of EPO in a
high-throughput setting.
12:00 Determination of Recombinant Mammalian Cell Line Phenotypes in
the Bioreactor at the 96-DeepWell Plate Scale during Cell Line Development
Using Intact MALDI-ToF Mass Spectrometry and PLS-DA Modeling
Here we described the application of an intact cell MALDI-ToF mass spectrometry
fingerprinting method coupled with mathematical modeling to the cell line construction
process for the prediction and isolation of high producing cell lines. We show how
MALDI-ToF mass spectrometry data of cell lines gathered at the 96 deep well plate
stage of cell line construction can be used to predict the phenotype of mammalian cell
lines at the 10 L fermenter scale using a Partial Least Squares Discriminant Analysis
(PLS-DA) model.The modeling approach provides the basis for the early prediction of
cell line performance in cGMP manufacturing-scale bioreactors. We will discuss the
possibility of extending the application to product quality attributes.
Lunch onYour Own
13:30 Session Break
SINGLE-USE, MONITORING QUALITY
& PROCESS EXCELLENCE STRATEGIES
14:05 Case Study: Scale-Up of an Allogeneic CellTherapy Product
using Single-Use Systems
Ravinder Bhatia, MSc, Scientific Director, PDMS/API-LM, Janssen Research &
Development
One of the major challenges with cell therapy products is the development
of a robust and scalable process to produce the product for clinical trials and
commercialization. Currently, numerous technologies are available for the scale-
up of an allogeneic cell therapy product in static (e.g. T-flasks and cell factories) or
suspension (e.g. microcarriers, bioreactor type) cultures. In this presentation, a
case study will be presented on process development and scale-up of an allogeneic
human somatic cell therapy product using single-use technologies.
14:35 Combining Multi-Dimensional Fluorescence Spectroscopy and
Chemometric Analysis for Quantitative Bioprocess Monitoring
Multi-dimensional fluorescence spectroscopy (MDFS) was used for quantitative
predictive analysis of glycoprotein production and content in CHO cell fed-batch
process. MDFS spectra of complex solutions were sensitive to compositional
change and as cultivation progressed, amino acid, and glycoprotein product
emission varied as the chemical composition changed and culture progress could be
monitored quantitatively using a variety of multivariate analysis techniques. In one
case, unique dityrosine emission from product glycoprotein could be used to follow
product formation. The MDFS variance could also be used to generate quantitative
predictive models of process performance based on glycoprotein yield.
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15:05 Using Different QbDTools to Support Scale-Down and Scale-Up
of Bioprocesses: Examples from Small and Large Molecules
Jose C. Menezes, Ph.D., Professor, Bioengineering and Biosciences, Technical
University of Lisbon
The use of disciplines from the QbD (Quality by Design) tool box will be
demonstrated to support science-based bioprocess industrialization and
manufacturing (e.g., design-spaces, multivariate end-point and batch trajectory
control). Scale-up with PAT tools and/or validated scale-down models for DoE
and troubleshooting will be highlighted for small and large molecules. Process
performance and product quality will be considered in these approaches.
15:35 Monoliths as PATTools for Bioprocess Improvement
Oliver Spadiut, Ph.D., Group Leader, Integrated Bioprocess Development,
Biochemical Engineering, Vienna University of Technology
Monolithic columns are a special type of chromatography column which can be
used for the purification of different biomolecules. They have become popular due to
their high mass transfer properties and short purification times. However, they also
describe powerful PAT tools for bioprocess monitoring and development. I will show
how monoliths can be used as efficient impurity monitoring tools during bioreactor
cultivations but also across unit operations for recombinant protein production
processes with yeast.
16:05 Hybrid Modeling as a QbDTool for PAT in Biopharma
Moritz von Stosch, Ph.D., Lecturer, Chemical Engineering and Advanced Materials,
Science, Agriculture and Engineering, Newcastle University; CEO, HybPAT
Technologies
Process understanding is at the heart of the PAT initiative and QbD paradigm.
The integration of Risk Analysis, Design of Experiments and Multivariate
Data Analysis (MVDA) is the predominantly applied approach in biopharma to
understand processes, nowadays. In this talk, it will be shown that the integration
of fundamental process knowledge along with MVDA into hybrid models has the
potential to improve the prediction performance, reduce the experimental effort and
support the knowledge exchange between scales.
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Pacheco 15,
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Presentations – Available Within the Main Agenda!
Showcase your solutions to a guaranteed, targeted audience. Package
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Opportunity includes a 30-minute podium presentation in the main session
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Invitation-Only VIP Dinner/Hospitality Suite
Sponsors will select their top prospects from the conference pre-
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CHI’s Lead Generation Programs will help you obtain more targeted,
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For more information, please contact:
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CURRENT SPONSORS AND EXHIBITORS
As of June 4, 2015
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Constant Systems Inc.
Fujifilm Diosynth Biotechnologies
Genedata AG
HORIBA Instruments Inc.
IBIS Technologies
IntelliCyt Corporation
Isogenica Ltd.
Malvern Instruments Inc.
MaxCyte, Inc.
Novozymes
Pall ForteBio
PhyNexus, Inc.
ProteoGenix
Randox Biosciences
Reichert Technologies
Schrödinger
SensiQ Technologies Inc.
TSI GmbH
TTP Labtech
Unchained Labs
Vaccinex Inc
Wacker Biotech GmbH

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One short course €625 €375 €125
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Monday, 2 November (Morning Short Courses) Thursday, 5 November (Dinner Short Courses)
SC1: Engineering of Bispecific Antibodies SC6: Troubleshooting and Engineering of Antibody Constructs
SC2: Mutation and Selection Strategies for Multi-Parameter Antibody
Optimisation
SC7: Immunotherapy in the 21st Century: More Specificity, More Potency, Better
Targeting
SC3: CHO Cell Engineering SC8: The Challenge of Protein Aggregation and Formation of Sub Visible Particles
in the Development of Biopharmaceuticals
SC4: Protein Purification Strategies: Dealing with Proteins that Are Prone to
Aggregate
SC9: Advanced Techniques for Characterisation of Protein Aggregates,
Particulates and Contaminants
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Antibody Engineering Stream 1A: Display of Antibodies 1B: Bispecifics and Novel Products 1C: Cancer Biotherapeutics
Biologics Development Stream 2A: Optimisation & Development 2B: Aggregates & Particles 2C: Characterising Biotherapeutics
Impurities & Stability Stream 3A: Purification Technologies 3B: Aggregates & Particles 3C: Formulation & Stability
Bioproduction Stream 4A: Purification Technologies 4B: Bioreactor Design & Engineering 4C: Bioproduction: Scaling-Up & Down
Protein Expression Stream 5A: Engineering Expression Systems 5B: Applying Expression Platforms 5C: Bioproduction: Scaling-Up & Down
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Pegs Europe 2015 Protein & Antibody Engineering Summit

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Pegs Europe 2015 Protein & Antibody Engineering Summit