Partners from Work Package 1, which focuses on Manufacturing and Preparation, held their second Scientific Data Gathering meeting in Edinburgh where excellent progress was noted against the development of a toolbox to support manufacturers and developers to address common issues and promote best practice in ATMP manufacturing and preparation.
Key components of the toolbox include:
- A template for flow cytometry, to help address the variability in starting material between manufacturing sites,
- A template for the use of sporicidal disinfectants, to provide an evidenced response to regulators as to why particular disinfectants are chosen, and
- A template for freezing and thawing of starting material and final products to avoid discrepancies and non-comparability between manufacturing sites
Presentations were delivered by the Newcastle Cellular Therapies Facility team on these templates and partners agreed next steps, including using the templates in practice.