New Members sought for the Advanced Therapy Medicinal Products Working Party (ATMP WP)

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: “Empty Capsids for AAV Products”. Members should be able to fulfil the below criteria.

Essential Criteria

  • Experience in analytics of AAV vectors (development, validation, and routine analysis).
  • Experience in assessing the presence and contribution of full / empty / partial capsids.
  • Have a good understanding of the mechanism for empty capsid production and methods for assessing their contribution to product quality and therefore risk to patient safety.
  • Expertise in using and implementing control strategy requirements for one or more methods used for determining the presence and / or contribution to efficacy of empty / partial capsids; including but not limited to: AUC, TEM, and HPLC.

OR

  • Expertise in using and implementing control strategy requirements for one or more methods used for determining the presence and integrity / fragmentation of encapsidated DNA within AAV capsids; including but not limited to: NAT-based methodologies and next generation sequencing / long read sequencing techniques (including library preparation and associated Bioinformatics analysis).

Desired Criteria

  • Experience preparing in-house standards of full / empty capsids.
  • Have a good understanding of existing guidelines and best practices related to empty capsids of quality in a regulatory environment.
  • Be available for a MS Teams Meeting on 26th November 14:00-15:00.

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 midday on 10th November 2021.