SC9: INTRODUCTION TO BIOPHYSICAL ANALYSIS FOR BIOTHERAPEUTICS: DEVELOPMENT APPLICATIONS

TUESDAY, APRIL 9, 6:00-8:30 PM (DINNER COURSE) (Washington)

Instructor: Christine P. Chan, Ph.D., Principal Scientist, Global Manufacturing Science & Technology, Sanofi

Biotherapeutics are challenging to develop due to complexity of the molecular structure as well as the manufacturing process. Biophysical methods are crucial tools for analytical characterization of biotherapeutics and are routinely used in all stages of the product lifecycle including: the initial screening of candidates for potential development liabilities, further characterization of the higher order structure (HOS), identifying optimal conditions to assure stability, and demonstrating HOS preservation during manufacturing, storage and administration.

This short course provides an overview of the common biophysical techniques used for HOS characterization in biologics development and their application considerations. Key topics include:

• Defining a stability-indicating profile, phase-appropriate considerations
• Biophysical technologies highlight: spectroscopic methods, calorimetry, light scattering, analytical ultracentrifugation, high resolution methods, aggregation and particle analysis
• Stress study conditions: product instability and process/manufacturing operations
• Fit-for-purpose considerations: method capability, qualification; overall data integration
• HOS characterization in comparability & biosimilarity studies
• Practical examples and discussions

INSTRUCTOR BIOGRAPHY:

Christine P. Chan, Ph.D., Principal Scientist, Global Manufacturing Science & Technology, Sanofi

Dr. Christine Chan is a protein biochemist with broad experience in the biopharmaceutical industry, including prior experience at Sandoz Pharmaceuticals and Merck & Co., Inc. She specializes in the analysis of recombinant products produced from mammalian cells for vaccines and biologics development. Her application experience includes expression cell line selection, drug substance & drug product process development, manufacturing tech transfers and lifecycle management of commercialized products. Dr. Chan received her Ph.D. from the University of California-Davis and conducted post-doctoral work at the University of Washington. She has authored over 30 publications with two recent reviews on forced degradation studies on protein-based therapeutics and stability testing considerations.