New FDA Draft Guideline regarding the Use of Human- and Animal-derived Materials

The FDA's guidance focuses on the expectations for safety and quality testing of human- and animal-derived materials used in manufacturing cell and gene therapy products, as well as Tissue Engineered Medical Products (TEMPs). It details the requirements for chemistry, manufacturing, and control (CMC) information that should be included in an investigational new drug application (IND).

Key aspects covered in the guidance include donor screening and testing, testing and screening for adventitious agents, risk assessment, and management of materials. The guidance specifically addresses materials such as human or animal blood, antibodies from animal hybridoma cells, and cytokines produced in insect cell lines.

The document emphasizes the importance of demonstrating in regulatory submissions how manufacturing methods for these materials effectively remove adventitious agents. It also highlights several critical considerations when using human- and animal-derived materials, such as the risk of transmitting adventitious agents, consistency between material lots, material identity, and overall material qualification.

For IND submissions, sponsors are required to provide the FDA with a comprehensive list of all materials used in the manufacturing process, along with descriptions of their quality and grades, presented in a tabular format. Additionally, submissions must comply with the Common Technical Document (CTD) sections 3.2.S.2.3 and 3.2.P.4, which pertain to the control of materials and excipients, respectively.

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.

Read the full draft guidance "Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products" on the FDA website. The deadline to comment is 29 July.

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