Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products April 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2024-D-1244
• Issued by: Center for Biologics Evaluation and Research

The use of human- and animal-derived materials  to manufacture cellular and gene therapy (CGT) products and tissue-engineered medical products (TEMPs) raises several key issues to consider, including transmission of adventitious agents, material lot-to-lot consistency, and material identity, as well as general material qualification considerations.  We, FDA, are providing you, manufacturers of CGT and TEMP products, with recommendations regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of these products.  In addition, recommendations are provided regarding the chemistry, manufacturing, and control (CMC) information submitted in an investigational new drug application (IND) relating to the use of human- and animal-derived materials.

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 (Gene Therapy CMC Guidance) (Ref. 2) 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 (Cell Therapy CMC Guidance) (Ref. 3). 

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