トレーニングセミナー | Bioprocessing Summit Europe 2024 公式サイト

Cambridge Healthtech Instituteのトレーニングセミナーでは、学術的理論から背景事情などの幅広い領域をカバーすると共に、実際のケーススタディや直面した課題、適用した解決策などを提供しています。各トレーニングセミナーは、正式な講義と対話型の議論・活動とを組み合わせて、最大限の学習効果を得られるように設計されています。これらのトレーニングセミナーでは、経験豊富な講師陣が現在の研究に応用できる内容に焦点を当て、その分野を初めて学ぶ方にも有用なガイダンスを提供します。

トレーニングセミナーは対面形式でのみ提供されます。

2024年3月20日（水） 14:00 - 16:30 | 2024年3月21日（木） 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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