Tuesday, August 16
SC5: Analytical Strategies for Comparability in Bioprocess Development
Bioprocess changes can impact quality attributes of biologics and may affect 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 short course, we will discuss the key concepts of establishing product quality profiles, defining control strategies, the common analytical characterization technologies used, and the hierarchical assessment approach to demonstrating comparability of the product in support of process changes.
- Defining product critical quality attributes; limits of acceptable variations
- Analytical characterization strategies: Common biochemical, biophysical and potency assays; emerging tools
- Conducting forced degradation studies, accelerated and long-term stability studies
- Test methods and specifications; lifecycle management
- Bioprocess impact on product quality: defining control strategies and change management; types of manufacturing changes and comparability study planning
- ICH guidance documents, practical examples and discussions
Christine P. Chan, Ph.D., Principal Scientist/Technical Lead, Global Manufacturing Science & Technology, Specialty Care Operations, Sanofi
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.