This document summarizes a two-day conference on lyophilization taking place from April 27-28, 2016 in Iselin, New Jersey. The conference will discuss lyophilization technologies and techniques, with sessions on quality control, regulatory compliance, formulation, processing, and analytical methods. It will also feature two half-day workshops on April 29 on developing lyophilization cycles and tech transfer. The workshops will provide practical guidance on meeting QbD requirements and discuss challenges in developing lyophilized dosage forms.

1. Sponsored by
Highlights for 2016:
• J&J presents why lyophilization is no longer just a
downstream process
• Understand protein stability and its changes during
freeze drying
• Novo Nordisk assess aseptic spray drying as an
alternative to lyophilization
• Genzyme share their thoughts on commercial
competitiveness of lyophilized products
• Allergan discuss the optimal approach of lyophilization
scale-up
SMi Presents the 2nd Annual Conference and Exhibition on...
27 - 28
APRIL
2016Renaissance Woodbridge Hotel,
Iselin, New Jersey, USA
Lyophilization USA
PLUS TWO INTERACTIVE HALF-DAY POST-CONFERENCE WORKSHOPS
Friday April 29th 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
www.lyophilization-usa.com
Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711
Driving Lyo-Productivity through Practical
QbD and Advanced Technologies
@SMIPHARM
Workshop A
Lyophilization – Development Through Tech Transfer
Workshop Leader: Ralph Tarantino, PhD,
Pharmaceutical Consultant & Principal, Steritech Solutions, LLC
08.30 - 12.30
Workshop B
An Empirical Approach to Formulation and Lyophilization
Cycle Development of Parenteral and Diagnostic Products
Workshop Leader: J. Jeff Schwegman, CEO, AB BioTechnologies, Inc.
13.30 - 17.30
Chairs for 2016:
• Jim Searles, Ph.D., Technical Fellow, Pfizer
• Sune Klint Andersen, Principal Scientist, Novo Nordisk
Expert Speaker Panel Includes:
• Dr. Mark Yang, Director of Fill/Finish Development, Late
Stage Process Development, Genzyme Corp
• Dr Evgenyi Shalaev, Research Investigator, Allergan
• Prakash Sundaramurthi, Senior Scientist, Teva Biologics
• Dr. Vineet Kumar, Senior Scientist, J&J
BOOK BY JANUARY 29TH 2016 TO SAVE $400
BOOK BY FEBRUARY 29TH 2016 TO SAVE $300
BOOK BY MARCH 30TH 2016 TO SAVE $200

2. Lyophilization USA
Day One | Wednesday 27th April 2016
08.30 Registration & Coffee
09.00 Chair’s Opening Remarks
Jim Searles, Ph.D., Technical Fellow, Pfizer
REGULATORY COMPLIANCE – AGENCIES’
EXPECTATIONS FOR LYOPHILIZED PRODUCTS
09.10 OPENING ADDRESS: Effect of Pressure and Dryer Load upon
Secondary Drying Rates
•Fundamentals of the secondary drying phase
•Effects of process parameters such as temperature and
pressure
•In-depth focus upon dryer load and pitfalls of scale-up
Jim Searles, Ph.D., Technical Fellow, Pfizer
09.50 Regulatory Uncertainty vs. Product Development
•US-FDA specific requirements vs. critical issues for regulatory
approval in the EU
•What is required by the regulators for quality control and
CMC?
•How to accelerate approvals working simultaneously for
both markets?
David Awotwe-Otoo, Division of Product Quality Research,
FDA (Invited)
10.30 Morning Coffee & Networking Break
FROM FORMULATION TO BIO-PROCESSING
11.00 When Lyophilization is No Longer Just a Downstream Process
•Dealing with more complex biologics from early stages
•Predictive modelling and high throughput screening –
ensuring stability of compound during freeze drying
•Latest simulation technologies to decrypt molecular
structure
Dr. Vineet Kumar, Senior Scientist, J&J
11.40 Residual Water Content in a Lyophilized Drug Product –
Optimizing Secondary Drying
•How dry should it be? Determining ideal water content for
drug products
•How to customize your drying process
•Analytical methods to best analyze effect of residual water
on stability
Lisa Hardwick, Research Scientist, Baxter Healthcare Corporation
12.20 Protein Stability: Change in the Apparent Acidity During
Freezing and Drying
•Stability concerns over lyophilized-products
•Excipients to enhance stability and shelf-life
•Interaction with APIs
•Search for the optimal pH for lyophilization
Dr. Evgenyi Shalaev, Research Investigator, Allergan
13.00 Networking Lunch
14.00 QbD – How, What and When?
•Quality by design (QbD) – what exactly is QbD?
•Defining critical attributes and incorporating into drug
development plan
•How will this improve lyophilization process and what are
the challenges?
•From concept to implementation
Speaker to be announced shortly
14.40 Aseptic Spray Drying as an Alternative to Lyophilization?
•Recent breakthroughs in aseptic spray drying technologies
for commercial production
•Approaches for aseptic powder filling
•Comparison of aseptic drying processes
Sune Klint Andersen, Principal Scientist, Novo Nordisk
15.20 Afternoon Tea & Networking Break
TECHNOLOGICAL ADVANCEMENTS IN LYOPHILIZATION
15.50 Process Analytical Technology (PAT) to Develop a Rational
Lyophilization Cycle
•A key attribute not to be neglected – proving PAT to
regulatory agencies
•Update on PAT guidelines and what should be classed as
critical process parameters?
•Developing a PAT toolbox – from single vial to batch
monitoring
•Assurance of product quality and regulatory compliance
Session reserved for sponsor
16.30 Panel Discussion: Is Lyophilization the
Way to Go Forward?
•Exploring current market trends for
pharmaceutical products and needs for lyophilization
•Marrying sciences with commerciality – scalability and
product quality
•Exploring the alternatives to lyophilization
Moderators:
Dr. Salman Mazummil, Drug Product Development, Janssen
Dr. Padam N. Sharma, Ph.D., Injectables, Sterile
Manufacturing and Development Global Pharmaceutical
Technology, Allergan
17.10 Chairman's Closing Remarks and Close of Day One
Register online at: www.lyophilization-usa.com • Alternatively fax
SPONSORSHIP AND EXHIBITION OPPORTUNITIES
SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your
company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your
client base within the context of an independent discussion specific to your industry. Should you wish to join
the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on
+44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk
Sponsored by Official Media Partners
One 2 One™ is a global leader in sterile injectables contract
manufacturing. We carefully guide your medicine from
development through launch, harnessing 25+ years of expertise in
biopharmaceutical fill and finish. Organizational strengths include
in-depth experience with complex biologics and a lyophilization
center of excellence. www.one2onecmo.com

3. Lyophilization USA
Day Two | Thursday 28th April 2016
08.30 Registration & Coffee
09.00 Chairman's Opening Remarks
Sune Klint Andersen, Principal Scientist, Novo Nordisk
QUALITY CONTROL AND COMPLIANCE FOR LYOPHILIZATION
09.10 OPENING ADDRESS: Commercial Competitiveness of
Lyophilized Products
•Lyophilization is often unavoidable for biologics and is a
growing market
•Strategies to reduce lyophilization cycle and cost for
commercial manufacturing
•New technologies that can shorten lyophilization
development time and improve its efficiency
•Dried but not lyophilized? Technologies beyond
lyophilization
Dr. Mark Yang, Director of Fill/Finish Development,
Late Stage Process Development, Genzyme Corp
09.50 Controlled Nucleation – Reliability and Consistency?
•Project updates on controlled nucleation
•How to ensure process consistency and homogeneity of
products – physio-chemical characterization?
•Overcoming regulatory uncertainty
•Scaling up – the need for a robust monitoring and
surveillance system
Speaker to be announced shortly
10.30 Morning Coffee & Networking Break
11.00 Excipient Behaviour in Frozen and Freeze-Dried Systems
– Potential Impact on Product Performance
•Buffers, bulking agents and lyoprotectant
•Characterization techniques
•Implications on processing and final product performance
Dr. Raj Sury, Professor, University of Minnesota
11.40 Solute Behavior in Sub-Zero Temperatures – Impact on
Freeze-Dried Products – Case Studies
•Lyophilization from two immiscible liquids at sub-zero
temperature
•Condenser temperature as CPP
•Scale-up issues with vial fogging
Prakash Sundaramurthi, Senior Scientist, Teva Biologics
12.20 Networking Lunch
MAXIMIZING PRODUCTIVITY AND EFFICIENCY
13.20 Quality Assessment for Lyophilization and Lyophilized
Products
•From sterilization to an accurate fill/finish dosage
•The evolving and emergence of complex and combination
products – requirements for PFS
•GMP and define standard operating procedures (SOPs) for
your CMOs
Session reserved for sponsor
14.00 Freeze Thaw for Protein Stabilization
•How to store and what temperature range is optimal?
•Freeze thaw process – will this impact on drug quality and
efficacy?
•Product stability during storage – eliminating crystallization
and extending shelf-life
Jamie Tsung, Principal Scientist, Drug Product Development,
Momenta Pharmaceuticals
14.40 Afternoon Tea & Networking Break
15.10 Comparability Studies for Tech Transfer in Lyophilization
•Designing tech transfer program of lyophilization cycle to
improve success rate
•How to minimize workload and overcome key challenges of
ice nucleation and bulk formulation
•Enhancing performance of drying
•Site and plant selection
Session reserved for sponsor
15.50 Panel Discussion: Looking Beyond
– Is Drying the Only Way to Go?
•How dry should it be? Determining water
content for drug products
•How to customize your drying process?
•Stability prediction and modelling
Panellists:
Sune Klint Andersen, Principal Scientist, Novo Nordisk
Prakash Sundaramurthi, Senior Scientist, Teva Biologics
Dr. Raj Sury, Professor, University of Minnesota
16.30 Chairman’s Closing Remarks and Close of Day Two
Supported by
x your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711
Want to know how you can get involved? Interested in promoting your services to this market?
Contact Teri Arri, SMi Marketing on +44 (0) 207 827 6162 or email: tarri@smi-online.co.uk
Official Publications

4. Overview of the Workshop:
Thishalf-dayworkshopwillaimtoprovidepracticalexperiencefor
delegates on meeting QbD requirements and other CMC
challenges encountered in the development of lyophilized
dosage forms. The impact of lyophilization as a pharmaceutical
unit operation is expected to grow as the biopharmaceutical
market continues to expand. Hence, a well-defined
developmentandtechtransferplanbasedonQbDprincipleswill
mitigate downstream risks and ensure smooth scale-up, approval
and launch of lyophilized products.
Key Benefits of Attending:
Through interactive discussions and case reviews, this workshop
will help you to address all the above challenges relating to
parallel trade. You will be able to re-assess the best strategy and
option suitable to your business including pricing and supply
management.
08.30 Registration & Coffee
09.00 Workshop Leader's Opening Remarks
09.10 Developing a Thorough Development Plan to Meet
CMC Requirements
• Which regulatory technical requirements impact
most for complex biologics and combination
products?
• Incorporating QbD into product development
• Examples and challenges
09.40 Roundtable Discussion - Criticality Analysis for
Lyophilization
• CQAs and CPPs
• Documentation
• Examples/challenges
10.10 Roundtable Discussion
Workshop attendees will be encouraged to share
their challenges and experiences, and together
seek best solution to assist with a successful drug
development and lyophilization program
10.30 Morning Coffee
11.00 Lyophilization: Tech Transfer and Scale-Up
• Check off list for scale-up
• Process equipment considerations
• Validation issues
• Examples/challenges
11.40 Roundtable Discussion
12.00 Q&A
12.30 Closing Remarks from Workshop Leader and
End of Workshop
About the Workshop Host:
Ralph Tarantino, PhD, Pharmaceutical Consultant &
Principal, Steritech Solutions, LLC
Dr. Tarantino is a Subject Matter Expert in the
formulation of injectable dosage forms, with over 25
years’ experience in the pharmaceutical industry. He
was instrumental in the development of numerous marketed
drugproducts.Hisexperiencerangesfrombenchlevelscientistto
senior manager at Hoffmann-La Roche Inc. where he was the
DirectorofSterileProductFormulationandClinicalManufacturing
for 17 years. Dr. Tarantino specializes in peptide/protein
formulations, drug delivery systems and the solubilization of new
molecular entities. He has trained FDA reviewers on the topic
of peptide/protein formulation and mentored numerous
undergraduate and graduate scientists in the development and
manufacture of sterile products.
Currently he serves as consultant to pharmaceutical, investment
and legal firms. His projects have included evaluation of drug
delivery technologies, expert testimony in formulation related
cases and criticality analyses of drug product formulation and
manufacture.
Highlights of Dr. Tarantino's Career:
Leadership role in development of 9 marketed products and Sterile
Product Subject Matter Expert for Sterile products at Roche Nutley
Global Peptide Delivery Champion. Head of Sterile Clinical
Manufacturing with 7 successful Pre-Approval Inspections Extensive
FDAinteractionsandFDAtrainerforBiopharmaceuticalFormulation
and Stability Leader in international harmonization and Chair
International Formulation technology Working Group for Sterile
Products Invited Lecturer, American Association of Pharmaceutical
Scientists Eastern Regional Meeting, “Technology Transfer for Sterile
Dosage Forms” Adjunct Assistant Professor in Pharmaceutical
Sciences,LongIslandUniversityElectedChair,BasicPharmaceutical
Sciences, Academy of Research and Science, Basic
Pharmaceutical Sciences Representative, Education Standing
Committee, American Pharmaceutical Association.
HALF-DAY POST-CONFERENCE WORKSHOP A
Friday 29th April 2016
08.30 - 12.30
Renaissance Woodbridge Hotel, Iselin,
New Jersey, USA
Lyophilization – Development
Through Tech Transfer
Workshop Leader:
Ralph Tarantino, PhD, Pharmaceutical Consultant &
Principal, Steritech Solutions, LLC

5. Overview of the Workshop:
This seminar will cover the benefits of developing an
optimized formulation for freeze-dried products to improve
the quality and consistency, while also reducing the cycle
time and costs. This session will include all of the aspects of
understanding the justification for freeze-drying, the thermal
properties of the formulation (crystalline, amorphous,
mixed), the analytical techniques employed to
characterized these systems, and how all of this information
is used to develop a stable, optimized, cGMP compliant
product.
13.30 Registration & Coffee
14.00 Workshop Leader's Opening Introduction
14.10 From Proof of Concept to Design of
Experience (DoE)
• Why early stage formulation is important to
lyophilization?
• What are the critical attributes and factors to
consider?
• How can we improve the stability and formula
to suit lyophilization?
15.15 Afternoon Tea & Networking Break
15.45 Scaling Up - Considerations and Preparation
• Tech transfer considerations and challenges
• PAT and freeze drying
• How to select the optimal temperature range
for your products
• QA and manufacturability in a commercial
scale
16.30 Q&A
17.30 Workshop Leader's Closing Remarks and
End of Workshop
About the Workshop Host:
J. Jeff Schwegman, CEO, AB BioTechnologies, Inc.
J. Jeff Schwegman, Ph.D. is the Founder and
CEO of where he develops formulations,
lyophilization cycles, determines residual moisture by
Karl Fischer, and provides thermal characterization studies
including freeze-drying microscopy and DSC.
He holds patents and develops new technologies within the
lyophilization field. Dr. Schwegman received his Ph.D. from
Purdue University in 2003, and in 2008 he founded AB
BioTechnologies which is a contract laboratory offering full
scale formulation, analytical and lyophilization development
of both small and large molecules. He routinely lectures
around the world and teaches courses on formulation,
stabilization and process development of lyophilized products.
About the Organization:
AB BioTechnologies, Inc. is a small, privately held company
located in Bloomington, Indiana, that is dedicated to
providing the highest quality service in formulation
development, lyophilization cycle development/ optimization,
analytical development, thermal characterization, and
education and training in the development of injectable drug
products and diagnostics.
Since we are a small, privately held company with minimal
overhead, we can complete your project in record time at the
lowest possible cost.
HALF-DAY POST-CONFERENCE WORKSHOP B
Friday 29th April 2016
13.30 - 17.30
Renaissance Woodbridge Hotel, Iselin,
New Jersey, USA
An Empirical Approach to Formulation
and Lyophilization Cycle Development of
Parenteral and Diagnostic Products
Workshop Leader:
J. Jeff Schwegman, CEO, AB BioTechnologies, Inc.

6. FAX your booking form to +44 (0) 870 9090 712
PHONE on +44 (0) 870 9090 711
POST your booking form to: Events Team, SMi Group Ltd, 2nd Floor
South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, UK
LYOPHILIZATION USA
Conference: Wednesday 27th April & Thursday 28th April 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
Workshops: Friday 29th April 2016, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA
4 WAYS TO REGISTER
www.lyophilization-usa.com
If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk
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on the Document Portal $799.00 + VAT $958.80
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for those EU Customers not supplying a registration number for their own country here.
______________________________________________________________________________________________
CONFERENCE PRICES
I would like to attend: (Please tick as appropriate) Fee Total
□ Conference & 2 Workshops $2997.00
□ Conference & 1 Workshop AM □ PM □ $2398.00
□ Conference only $1799.00
□ 2 Workshops only $1198.00
□ 1 Workshop only AM □ PM □ $599.00
PROMOTIONAL LITERATURE DISTRIBUTION
□ Distribution of your company’s promotional
literature to all conference attendees $1598 + VAT $1917.60
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