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The
How and Why of Protein Aggregation: Tools, Interpretations,
and Correlations
Diversity and Complexity of Protein
Aggregation
Tudor Arvinte, Ph.D., Professor, University of Geneva;
Chairman and Chief Executive Officer, Therapeomic, Inc.
Detection
and Quantitative Characterization of Aggregates
Detection and Quantitative
Characterization of Protein-Protein Interactions in Highly
Concentrated Solution
Allen P. Minton, Ph.D., Chief, Section on Physical
Biochemistry, National Institute of Diabetes and Digestive and
Kidney Diseases, National Institutes of Health
Analysis
of Aggregates and Sub-visible Particles in Protein Solutions
Detecting Aggregates in Protein
Therapeutics without Sample Separation or Dilution by
Low-angle Dynamic Light Scattering
Roland Schmidt, Ph.D., Principal Scientist, Manufacturing
Science and Technology, Abbott Laboratories
Analysis of Aggregates and
Sub-visible Particles in Protein Solutions: Case Studies
Yijia Jiang, Ph.D., Principal Scientist, Formulation and
Analytical Resources Department, Amgen
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(SC5)
Dinner Presentation and Interactive Panel Discussion* |
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Focus on Aggregation: Mechanisms, Analytical Methods, and Real-World
Examples
Presenter
and Panel Moderator: John Philo, Ph.D., Vice President,
Biophysical Chemistry, Alliance Protein Laboratories
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Types
and mechanisms of aggregation
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Why characterization methods in addition to SEC are often
requested by the regulators
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Basic principles of orthogonal analytical methods
analytical ultracentrifugation (AUC), field-flow
fractionation (FFF) and light scattering techniques (SEC-MALS
and DLS)
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Advantages and disadvantages of all these analytical
methods
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Real-world examples and applications to illustrate a range
of aggregation issues and mechanisms that may be
encountered and how these various analytical methods can
be applied
Panelists:
Yijia
Jiang, Ph.D., Principal Scientist, Formulation and Analytical
Resources Department, Amgen
Tudor Arvinte, Ph.D., Professor, University of Geneva;
Chairman and Chief Executive Officer, Therapeomic, Inc.
Mary Cromwell, Ph.D., Scientist & Senior Group Leader,
Early Stage Pharmaceutical Development, Genentech
*
Separate registration is required
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The
Impact of Production on Protein Aggregation
Opening
Talk
Bioproduction:
Many Sources of Protein Aggregation
Mary Cromwell, Ph.D., Associate Director and Senior
Scientist, Protein Analytical Chemistry, Genentech
Influence of Formulation on the
Success of Protein Drugs
Tudor Arvinte, Ph.D., Professor, University of Geneva;
Chairman and Chief Executive Officer, Therapeomic, Inc.
Mechanical Stress Stability of
Monoclonal Antibody Formulations
Sylvia Kiese, Formulation Scientist, Pharmaceutical R&D
Biologics, F. Hoffmann-La Roche Ltd.
Characterizing
Aggregation to Improve Product Yield and the Purification
Process
Characterization of Soluble
Aggregates in Formulation Development
Sambit R. Kar, Ph.D., Principal Scientist, Pharmaceutical
R&D, Pfizer Global Biologics
A Case Study Detailing the
Application of Analytical Methods to Characterize Protein
Aggregation for a Biopharmaceutical Drug Program
Jennifer F. Nemeth-Seay, Ph.D., Principal Research
Scientist, Head, Discovery Mass Spectrometry, Centocor
Research and Development
Aggregates Removal by Hydrophobic
Interaction Chromatography
Min Zhu, Ph.D., Scientist, Process Biochemistry, MedImmune
Overcoming
Challenges to Protein Formulation and Aggregation in the
Frozen State
Avoiding Aggregation in Bulk
Freeze and Thaw – How Much and What Kind of Control you Need
– A Controversy
Roland Schmidt, Ph.D., Principal Scientist, Manufacturing
Science and Technology, Abbott Laboratories
Protein Aggregation in the Frozen
State due to Excipient Crystallization
Deirdre Piedmonte, Ph.D., Senior Scientist, Formulation and
Analytical Resources, Amgen
Biological
Effects of Protein Aggregates
The Role of Aggregates Inducing
Antibody Responses Against Protein Therapeutics
Philippe Stas, Chief Executive Officer, Algonomics;
President European Immunogenicity Platform
AAA-ATPase p97/VCP: Cellular
Functions, Disease and Therapeutic Potential
Neeraj
Vij, M.S., Ph.D., Division of Pediatric Respiratory Sciences
& Institute of NanoBioTechnology, The Johns Hopkins School
of Medicine
For questions or suggestions about the meeting, please contact:
Micah Lieberman
Cambridge Healthtech Institute
T: (+1) 541.482.4709
E: mlieberman@pharmaseries.com
For exhibit, partnering and sponsorship information, please contact:
Carol Dinerstein
Business Development Manager
Cambridge Healthtech Institute
T: (+1) 781.972.5471
E: dinerstein@healthtech.com
For marketing and media partnerships, please contact:
Jennifer Devine
Senior Marketing Manager
Cambridge Healthtech Institute
T: (+1) 781.972.5485
E: jdevine@healthtech.com
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