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# Human/Animal Materials in Cell/Gene Therapies Guide
- URL: https://www.fdaweb.com/human-animal-materials-in-cell-gene-therapies-guide/
- Published: 2024-04-29T12:00:00.000Z
- Updated: 2026-09-14T14:29:30.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156872

FDA has released a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/considerations-use-human-and-animal-derived-materials-manufacture-cell-and-gene-therapy-and-tissue?ref=fdaweb.com) entitled “Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products.” The document says that the use of human- and animal-derived materials to manufacture cellular and gene therapy products and tissue-engineered medical products 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. The guidance provides recommendations on “assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of these products.” Additionally, it offers recommendations on the chemistry, manufacturing, and control information submitted in an IND.