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Co-Located Conference
Paid delegates for BioProcess International TM Conference & Exhibition may attend the sessions of this conference at no additional charge.
IBC’s 10 th Annual
Formulation Strategies for Protein Therapeutics
A Case Study Forum on Improving the Pace and Quality of Formulation Development
September 21-23, 2010 • Rhode Island Convention Center • Providence, RI
For further information, and to access the speaker presentation abstracts, please visit:
www.IBCLifeSciences.com/Formulation
Tuesday, September 21, 2010
Pre-Conference Workshop:
The Formulator of the Future: Using High
Throughput Technologies, Informatics and
Rational Design to Accelerate and
Optimize Formulation Development
7:45 Registration and Networking Coffee
8:25 Chairperson’s Remarks
David Volkin, Ph.D., Distinguished Professor, Pharmaceutical
Chemistry, University of Kansas
8:30 Application of a High Throughput Screening Procedure
with PEG-induced Precipitation to Compare Relative
Protein Solubility during Formulation Development
with IgG1 Monoclonal Antibodies
Todd Gibson, Ph.D., Senior Research Scientist, Johnson & Johnson
Pharmaceutical R&D, Inc.
9:00 Critical Analysis of Multiple Complex Datasets
in Solving Challenges during Formulation
Development and Protein Characterization
Haripada Maity, Ph.D., Senior Scientific Manager, Formulation
Development, ImClone Systems, A Wholly-Owned Subsidiary of
Eli Lilly & Co.
9:30 CASE STUDY Characterization of Stability
Characteristics of Drug Candidates in Discovery Research
Sharon Gao, Ph.D., Principal Scientist, Analytical Biochemistry,
Biogen Idec, Inc.
10:00 Networking Refreshment Break
10:30 CASE STUDY Incorporation of Fluorescence-Based
Screening Technique to High-Throughput, Gated
Workflow for Biologic Formulation Screening
Pooja Arora, Ph.D., Research Investigator II, Bristol-Myers Squibb
11:00 Finding the Perfect Lead: Strategies to Select Proteins
with Optimal Properties for Further Development
Hubert Kettenberger, Ph.D., Senior Scientist, Protein Analytics,
Roche Diagnostics GmbH, Germany
11:30 Panel Discussion with Workshop Speakers: Use and
Limitations of HTS in Formulation Development
12:00 Workshop Ends; Lunch on Your Own
Main Conference
1:10 Chairperson’s Remarks
Haripada Maity, Ph.D., Senior Scientific Manager, Formulation
Development, ImClone Systems, A Wholly-Owned Subsidiary of
Eli Lilly & Co.
Development of Formulation and
Drug Product Design Space
Keynote Presentation
1:15 Holistic QbD: The Integration of
Formulation, Process Development
and Process Validation
Sherry Martin Moe, Ph.D., Director, Late Stage
Pharmaceutical and Processing Development,
Genentech, Inc.
2:00 CASE STUDY Lyophilization Process Validation
based on Quality by Design
Bingquan (Stuart) Wang, Ph.D., Senior Scientist, Pharmaceutics,
Genzyme Corporation
Keynote Presentation
2:30 Particles, Particles Everywhere: Causes,
Consequences and Control of Aggregates
and Subvisible Particles in Therapeutic
Protein Formulations
John F. Carpenter, Ph.D., Professor, Department of
Pharmaceutical Sciences, University of Colorado
3:15 Networking Refreshment Break
Comparability and Characterization Exercises
during Formulation Development
3:45 CASE STUDY Comparability Assessments with
Protein Therapeutic and Vaccine Dosage Forms:
Challenges and Opportunities
David Volkin, Ph.D., Distinguished Professor, Pharmaceutical
Chemistry, University of Kansas
4:15 Characterization of Site Specific Degradation Pathways
of Antibody-Maytansinoid Conjugates (AMC)
Alex Lazar, Ph.D., Mass Spectrometry Group Leader, Analytical
and Pharmaceutical Sciences Department, ImmunoGen, Inc.
4:45 CASE STUDY Evaluating the Impact of a
Container Closure Change on the Stability
of a Protein Therapeutic
Angela W. Blake-Haskins, Ph.D., Senior Scientist II, Drug Product
Sciences Department, Human Genome Sciences, Inc.
5:15 Session Ends
5:30 Opening Night Reception in the Exhibit and Poster Hall
Sponsored by
Wednesday, September 22, 2010
7:45 Networking Coffee
8:10 Chairperson’s Remarks
Angela W. Blake-Haskins, Ph.D., Senior Scientist II, Drug Product
Sciences Department, Human Genome Sciences, Inc.
Keynote Presentation
8:15 Modeling Protein Degradation Processes
and the Development of Rational
Approaches to Stabilization
Bernhardt Trout, Ph.D., Professor, Chemical
Engineering, Massachusetts Institute of Technology
Implementing Analytical Methods and
Control Steps for Subvisible Particles
Keynote Presentation
9:00 NIST Perspective on Standards and
GMP Processes for Subvisible Particles
in Protein Therapeutics
Dean Ripple, Ph.D., Group Leader, Process Measurements
Division, Process Sensing Group, National Institute of
Standards and Technology
9:45 Networking Refreshment Break in Exhibit and Poster Hall
Sponsored by
10:30 Does SEC-HPLC Tell the Whole Story Use of
Orthogonal Methods to Detect Aggregates and
Subvisible Particles
Brian K. Meyer, Ph.D., Research Fellow,
Merck Research Laboratories
11:00 Analysis of Subvisible Particles by Flow Microscopy
Rajesh Krishnamurthy, Ph.D., Director, Analytical and
Pharmaceutical Sciences, ImmunoGen, Inc.
11:30 CASE STUDY Investigation of Therapeutic Protein
Particle Formation during Filling Operations
Shona C. Patel, Ph.D., Senior Development Engineer, Merck
Research Laboratories
12:00 Technology Workshop
For further information on sponsoring a Technology Workshop,
please contact Jennifer McElligott at jmcelligott@ibcusa.com or
508-614-1672 for additional information.
12:30 Networking Luncheon in BioProcess International
Exhibit and Poster Hall
2:10 Chairperson’s Remarks
Andrea Ji, Ph.D., Scientist, Genentech, Inc.
Evaluation and Control of
Biopharmaceutical Stability
2:15 CASE STUDY Mitigation of Oxidation in
Therapeutic Proteins
Andrea Ji, Ph.D., Scientist, Genentech, Inc.
2:45 CASE STUDY Formulation Development of
Therapeutic Antibodies using High-throughput
Fluorescence and Static Light Scattering Techniques:
Role of Conformational and Colloidal Stability
Sathish Hasige, Ph.D., Senior Scientist, Formulation Sciences,
Process Biochemistry, MedImmune, Inc.
3:15 CASE STUDY The Impact of Prefilled Syringe
Leachables on Protein Stability
Xiaofeng Lu, Ph.D., Senior Scientist, Facet Biotech
3:45 Networking Refreshment Break in Exhibit and Poster Hall
Sponsored by
4:30 Low Volume, High-Throughput Thermal Analysis
of Proteins by Fluorescence Dye Binding using a
RT-PCR Instrument
Thomas Palm, Ph.D., Senior Research Investigator, Pharmaceutics,
Bristol-Myers Squibb Company
5:00 CASE STUDY The Importance of Understanding
the Physical State of Excipients in a Freeze-Dried
Formulation: Implications for Overall Product Quality
Juan Davagnino, Ph.D., Director, Biopharmaceutical Development,
KBI Biopharma, Inc.
5:30 CASE STUDY Effects of Surface Tension and
Excipient Binding on the Conformational
Stabilization of a Monoclonal Antibody
Suzanne J. Hudak, Associate Scientist, MedImmune, Inc.
6:00 Networking Cocktail Reception in Exhibit and Poster Hall
Sponsored by
Thursday, September 23, 2010
8:25 Chairperson’s Remarks
Pooja Arora, Ph.D., Research Investigator II, Bristol-Myers Squibb
Formulation Strategies for Vaccines
8:30 CASE STUDY Impact of Recombinant Albumin on
the Stability of a Malarial Antigen Vaccine
Phuong Tran, Ph.D., Senior Scientist, Research and Development,
Novozymes, Australia
9:00 CASE STUDY Examining and Correlating the Long
Term and Accelerated Stability of a Pneumococcal
Antigen Vaccine
Manvi Hasija, Ph.D., Sanofi-Pasteur, Canada
9:30 CASE STUDY Formulation and Process
Considerations for Stabilization of Live
Attenuated Typhoid Vaccine
Satoshi Ohtake, Ph.D., Senior Scientist and Senior Manager,
Aridis Pharmaceuticals
10:00 Networking Refreshment Break in Meeting Room
Formulation Impacts of Device and
Packaging Systems
10:30 Characterization, Modelization and Control of
Primary Packaging Surfaces to Minimize Non-
Native Aggregation of Therapeutic Proteins
Thomas Ballet, R&D Engineer, Advanced Technology,
Becton Dickinson Medical Pharmaceutical Systems
11:00 CASE STUDY Product Quality and Formulation
Considerations in the Development of a Delivery
System and Product Packaging
Joe Fire, Senior Device and Packaging Engineer,
Human Genome Sciences, Inc.
11:30 CASE STUDY The Influence of Formulation on
Delivery System Design, and Vice-Versa
Douglas Nesta, Ph.D., Director, Biopharmaceutical Technologies,
Biopharm R&D Unit, GlaxoSmithKline
12:00 Networking Luncheon, Last Chance for Exhibit and
Poster Viewing
1:25 Chairperson’s Remarks
Shan Jiang, Ph.D., Director, Formulations, Seattle Genetics, Inc.
Formulation Development for
Next Generation Biologics
1:30 CASE STUDY Formulation Development for
Antibody-Drug Conjugate (ADC) Brentuximab
Vedotin (SGN-35)
Shan Jiang, Ph.D., Director, Formulations, Seattle Genetics, Inc.
2:00 CASE STUDY Development and Implementation
of a Thermal Melting Assay for High-Throughput
Screening of Liquid Adenoviral Formulations
Pieter Rijken, Ph.D., Senior Scientist, Crucell, The Netherlands
2:30 CASE STUDY Formulation Development for
Subcutaneous Delivery of Plasma Derived Proteins
Sylvain Huille, Ph.D., Head of Department, Biopharmaceutical
Development, LFB Biotechnologies, France
3:00 Conference Ends
“This IBC conference
is a unique opportunity to
get an overview of the
latest developments in
protein formulation with the
technical experts from the
biotech industry”
– Sylvan Huille, Department Head, Formulation
Development, LFB France
15 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com