Analytical Strategies for Comparability in Bioprocess Development

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Presented by

Dr Christine P. Chan, Director in Global Manufacturing Science & Technology at Sanofi

About this talk

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 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.

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