FDA Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products (Catapult’s regulatory round-up – May 2024)

FDA has issued a draft guidance intended to sponsors of allogeneic cell-based medicinal products, to provide recommendations for determining the appropriate cell safety testing to support an Investigational New Drug Application (IND) or a Biologics License Application (BLA). Cell safety testing should be based on a risk analysis that considers the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating.

This guidance supplements the following two final guidances:

• “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry,” dated January 2020 and
• “Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs),” dated April 2008.

Comments can be submitted until 30 July 2024. Published on the 5th of June in Catapult’s regulatory round-up for May 2024.