T Cell and NK Cell Characterisation Assays - Advanced Therapy Medicinal Products Working Party

The British Pharmacopoeia Commission is currently looking to appoint new professional members within the next three weeks for a new group focussing on providing advice and guidance on the topic: “T cell and NK cell characterisation assays”. Members should be able to fulfil the below criteria.

Essential Criteria

• Experience in development and application of potency assays for Natural Killer (NK) cells and T cells (development, validation, and routine analysis).
• Good understanding of GMP-compliant manufacturing processes, in-process control monitoring, the mechanism of action for T cell derived ATMPs, and associated assessment of risks for in vivo use.
• Experience in developing or using target-specific cytotoxicity assays.
• Employment (current or previous) by University/Health sector OR Large Pharma OR by Instrument Manufacturers OR as a Qualified Person.

Desired Criteria

• Experience preparing in-house standards for cell potency assays.
• Have a good understanding of existing guidelines and best practices related to cell potency assays in a regulatory environment.

If you’re interested in becoming a member please e-mail your CV to Ryan Smith at Ryan.Smith@MHRA.gov.uk. The closing date for expression of interest is 2^nd December 2021. The group will meet via MS Teams on 16^th December 2021 14:00-15:00.