TS6C: Potency and Comparability for Cell and Gene Products
Day One, Thursday 15 November 2018, 14:00-17:00 hrs
Day Two, Friday 16 November 2018, 08:30-15:35 hrs

Room Location: Room 5B

Instructor:

Christopher A Bravery, PhD, Consulting Regulatory Scientist & Director, Advbiols

Introduction and Objectives:

Potency assays are an essential concept in determining the quality of any biological medicinal product/biologic. Extending this concept to cell, gene and tissue 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.

Change is inevitable and necessary both in development and over the post-approval product lifecycle. Whenever changes are made it is necessary to confirm they do not adversely impact the quality and therefore safety and efficacy of the product; this requires data beyond meeting current specifications. With any biological product this is challenging, for cell, gene and tissue products that cannot be fully characterised the challenges are greater still. Any development program should therefore aim to ensure the tools are in place to allow changes to be implemented. How characterisation and process development provide these tools will be discussed.

Who Should Attend?

Anyone involved in manufacturing, quality control, quality assurance, regulatory and/or R&D, including scientists, managers and directors, of cell gene or tissue products that are regulated as medicinal products, biologics, drugs or similar.

May prove useful for developers of other complex biological medicinal products/biologics.

This course is not intended for those who work in cell and tissue transplantation.

Learning Overview:

Potency

• What is potency?
• Why is potency so important?
• How do I develop potency assays?
• What are the regulatory expectations for potency assays?
• Case studies: What can be learned from previous experience?
• Interactive exercise: develop a potency strategy for a worked example product.

Comparability

• What is comparability?
• Why is meeting existing specifications not comparability?
• How do I apply the principles of comparability to highly variable products?
• Case studies: Common mistakes with comparability and their consequences.
• Interactive exercise: Spot the weaknesses and propose improvements to a worked comparability study.

About the Instructor:

Christopher A Bravery, PhD, Consulting Regulatory Scientist & Director, Advbiols

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.