Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products April 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2024-D-1243
• Issued by: Center for Biologics Evaluation and Research

Allogeneic cells of human origin may be expanded in culture to manufacture medical products consisting of live cells, inactivated cells, cell lysates, or other cell-based materials such as cell-derived particles.  We, FDA, are providing you, sponsors of allogeneic cell-based medical products, 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. 

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