Issue Date: April 29, 2024
Issued by: Center for Biologics Evaluation and Research
Topic(s): Gene Therapy
Status: Draft
Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products
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.
Download the Guidance Document
