2015 Archived Content
SC 4 - Analytical Strategies for Comparability in Bioprocess Development
Tuesday, August 4
Bioprocess changes can impact quality attributes of biologics and may affect efficacy and/or safety of the product. During development and throughout the product lifecyle, when process improvements are implemented, it is essential to gather sufficient data to support the conclusion that product safety or 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 defining critical product quality attributes, the common analytical characterization technologies used, considerations in process monitoring and controls, and the iterative process of 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 and long-term stability studies. Assay lifecycle management.
- Bioprocess impact on product quality; defining process control strategy. Types of manufacturing changes and comparability study planning.
- ICH guidance documents, practical examples and discussions.
Christine P. Chan, Ph.D., Principal Scientist/Technical Lead, Manufacturing Science & Technology, Genzyme – a SANOFI company
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 lifecyle management of commercialized products.
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