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New for 2022: Potency Masterclass Workshop
This workshop is included in the All-Access Conference & Potency Assay Masterclass Workshop Pass.
Led by Christopher Bravery, Consulting Regulatory Scientist at Advbiols on 5th December, this masterclass will focus on:
- Overview of what potency is, and what it is not
- Metrological principles and their application to bioassays
- Considerations when qualifying and validating bioassays
- Examples of potency assays for approved products (these will consume at least half of the time);
- Examples of a cell and gene therapy potency assays
- From initial ideas, through characterisation to the final potency method
- Clinical correlation
- Regulator objections and why.
Note: this workshop is aimed at those directly involved in developing potency assays. The case studies of real potency assays will delve deeply into the underlying science for each product discussed in order to understand why the approach was taken.
About Christopher Bravery
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.