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2024年3月20日（三） 14:00 - 16:30 | 2024年3月20日（四） 08:30 - 15:20
TS5B: Comparability and Potency Assays for Cell, Gene and Biotech Products
Comparability studies following process change is an inevitable part of drug development, but with wide ramifications for CMC and process development departments alike. Robust potency assays are fundamental also for comparability studies, process validation, and for stability testing. CHI's 1.5-day training seminar, Comparability and Potency Assays for Cell, Gene Therapy and Biotech products provides an in-depth look at the application of regulatory science and biological standardization to biological products; what is potency, and how potency assays differ between biotech and cell and gene therapy products; plus principles of comparability and how their application differs between biotech, cell, and gene therapy products.
INSTRUCTOR BIOGRAPHIES:
Christopher Bravery, PhD, Consulting Regulatory Scientist, Advanced Biologicals Ltd.
Christopher founded Consulting on Advanced Biologicals Ltd. at the end of 2009, in order to focus his activities within the Regenerative Medicine sector. Advbiols Ltd. provides EU regulatory services to the regenerative medicine industry in addition to business and regulatory research and analysis to identify and focus on the real barriers to commercialisation of regenerative medicine. Christopher has a PhD in xenotranplantation immunology and spent 8 years in biotech (Imutran Ltd., a Novartis Pharma AG Co., and Intercytex) before joining the MHRA as a quality (CMC) assessor (biologicals and biotechnology unit). During this time, Christopher was involved with national implementation of the new Advanced Therapies Regulation and also involved through his participation in the CHMP’s cell products working party (CPWP) in implementation at the EMA level including drafting guidelines.
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