New members sought for the Advanced Therapy Medicinal Products Working Party (ATMP WP) - RCV

The British Pharmacopoeia Commission is currently looking to appoint new professional members within the coming weeks for a new group focussing on providing non-mandatory guidance on the topic “Replication competent virus (RCV) assay”. Members should have current expertise in:

Essential criteria

• Expertise in the methodologies used for RCV testing of Lentivirus/Retrovirus AND/OR Adeno-associated virus products, including experience in optimizing the sensitivity and specificity of these assays.
• In-depth understanding of the quality assessment of gene therapy products, with a focus on in-process viral risk assessment, plasmid design, and cell bank testing, including experience in developing and implementing measures to prevent viral contamination.
• Strong knowledge of virology and the ability to apply this knowledge to the development and testing of gene therapy products, including experience in using positive controls to validate the accuracy of assays.
• Experience in the standardization of RCV assays OR the use of reference cell lines/cell banks OR ATMP manufacture scale-up and its impact on RCV detection OR the use of next-generation sequencing OR automation such as liquid handlers, robotic systems, or machine learning algorithms, with a focus on promoting best practices and ensuring consistency and safety during the manufacturing process.
• Experience in regulatory submissions and approvals of RCV assays.

Desired criteria

• Be available for a MS Teams Meeting on 25 May 14:00-15:30.

If you’re interested in becoming a member, please send your CV to BiolStandards@mhra.gov.uk 

The closing date for expression of interest is midday on 2 May 2023.