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• See unpublished data from industry leaders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
Gregory A. Weiss, Ph.D., Professor of Chemistry, Molecular Biology and
Biochemistry, University of California, Irvine
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
Recommended Short Course*
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
12:00 Conference Registration
COMBINED KEYNOTE SESSION
13:40 PEGS EuropeTeam Welcome
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
19:05 End of Day One
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
WEDNESDAY, 4 NOVEMBER
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
Jennifer McManus, Ph.D., Lecturer, Department of Chemistry, National University
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
Salvador Ventura, Ph.D., Professor, Biochemistry and Molecular Biology, Institute of
Biotechnology and Biomedicine, University of Barcelona
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.
18:15 Networking Reception in the Exhibit Hall with Poster Viewing
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
Antonio Ribeiro, Ph.D., Professor, Pharmaceutical Technology, University of Coimbra
Azinhaga de Santa Comba
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
17:00 – 17:30 Dinner Short Course Registration*
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Pegs Europe 2015 Protein & Antibody Engineering Summit

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