SC10: PHASE-APPROPRIATE ANALYTICAL AND PROCESS CONTROL STRATEGIES

TUESDAY, AUGUST 13 | 6:00 – 8:30 PM | DINNER PROVIDED

Waterfront 2

ABOUT THIS COURSE:

Biotherapeutics are challenging to develop due to complexity of the molecular structure as well as the manufacturing process. The establishment of an integrated control strategy for robust manufacturing is an iterative process based on sound science and quality risk management. In this short course, we will discuss key considerations in evolving the analytical and process control strategies through the course of product development.

WHAT YOU WILL LEARN:

• Linkage of process to product quality: from CQA assessment to process characterization, impact on product stability, critical material attributes considerations
• Process analytics: product attributes monitoring, impurities control
• Comparability studies; managing changes in process and analytical methods
• Towards a streamlined testing strategy: evolving the test panel and specifications through the product lifecycle
• Practical examples and discussions

INSTRUCTOR BIOGRAPHY:

Christine P. Chan, PhD, 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.