Analytical Strategies for Comparability in Bioprocess Development

Bioprocess changes can impact the quality attributes of biologics and may affect the efficacy and safety of the product. During development and throughout the product lifecycle, when process improvements are implemented, it is essential to gather sufficient data to support the conclusion that product safety and efficacy has not been adversely affected. This demonstration exercise requires careful planning of the comparability studies and is based on the background knowledge of protein structure, biological function, and clinical attribute profiles of the product accumulated during development.
In this webinar, I will discuss the key concepts of establishing product quality profiles, and the hierarchical assessment approach to demonstrating comparability of biopharmaceuticals in support of process changes.
Presented by Dr Christine P. Chan, Director in Global Manufacturing Science & Technology at Sanofi

Dr. Christine P. Chan is currently Director in Global Manufacturing Science & Technology at Sanofi. She 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.