FDA Considerations for the Use of Human-and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products (Catapult’s regulatory round-up – May 2024)

FDA has issued a draft guidance which provides recommendations regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of cellular and gene therapy (CGT) and tissue-engineered products (TEP). This guidance applies to reagents, feeder cells and excipients and other inactive ingredients in the drug product that are in direct contact with the starting material, intermediates, final products, and any materials used to manufacture reagents, feeder cells, and excipients, and materials incorporated in tissus engeneered medicinal products (TEMPs). Human cells used as starting material to manufacture human cells, tissues, and cellular and tissue-based products, including TEMPs are excluded.

The considereations include donor screening and testing, adventitious agent testing and screening, risk assessment, and materials management. This guidance also provides recommendation 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 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.

Public consultation is open until 30 Jul 2024. Published on the 5th of June in Catapult’s regulatory round-up for May 2024.