Senior Consultant Blake Bergam and Senior Principal/Head of Cell Therapy CMC Sara Mills published today on the topic of "Understanding FDA's Draft Guidance On Human- And Animal-Derived Materials In The Manufacture Of Cell & Gene Therapy" via Life Science Connect's cellandgene.com.
"In April 2024, the U.S. FDA released the draft guidance for industry Considerations for the Use of Human- and Animal-Derived Materials in the Manufacture of Cellular and Gene Therapy and Tissue-Engineered Medical Products.1 This guidance represents the FDA’s current thinking on the topic and is intended to supplement the following two guidances: Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs),2 published in 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),3 published in April 2008. The guidance discusses several key issues, including transmission of adventitious agents, material identity testing, and how to present a material qualification justification within a regulatory submission."
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