2019 Archived Content
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SC2: Potency Assay Development for Cell and Gene Therapy Products

Monday 18 March, 13:00 – 16:00

Instructor:
Christopher Bravery, Ph.D., Consulting Regulatory Scientist, Consulting on Advanced Biologicals Ltd.
Potency assays are an essential concept in determining the quality of any biological medicinal product/biologic. Extending this concept to cell and gene products is more challenging and often the most difficult aspect of characterising these products. The relevance of the approach taken is often challenged by regulators both during development and when seeking market approval. This workshop will lead you through the issues and how to develop an overall potency strategy.

  • What is potency and why is it so important?
  • How do I develop potency assays?
  • What are the regulatory expectations for potency assays?

Biography

Christopher-BraveryChristopher Bravery, Ph.D., Consulting Regulatory Scientist, Consulting on 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. CAB 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 spent most of his career working in regenerative medicine: starting with a PhD in xenotranplantation immunology he first moved into industry in 1998 when he joined Imutran Ltd (A Novartis Pharma AG Co.) developing novel transgenic pigs to treat human organ failure. Following the closure of Imutran, Christopher moved to Intercytex and subsequently made the transition to regulatory affairs by 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.