Webinar explains federal guidance on manufacturing of animal cells and tissues
Published: 08 Dec 2021
The field of veterinary regenerative medicine, which uses material from animal cells and tissues—such as living cells, serum, or bone—is rapidly changing the way care is being delivered to patients. This sector uses these animal products with the goal of repairing diseased or damaged tissues or organs.
For example, platelet-rich plasma is believed to stimulate repair of tendon injuries. PRP can also be injected directly into a joint to treat osteoarthritis, most often in horses.
The Food and Drug Administration posted a prerecorded webinar this fall explaining draft guidance documents on good manufacturing practices and donor eligibility for these animal cells, tissues, and cell- and tissue-based products, also known as ACTPs.
The webinar is an in-depth explanation of two draft guidance documents issued by the FDA Center for Veterinary Medicine and published this past September in the Federal Register, which provided product-specific recommendations to help developers of ACTPs meet FDA manufacturing requirements.
The first document, “Good Manufacturing Practices for Animal Cells, Tissues, and Cell- and Tissue-Based Products,” is a series of recommendations for meeting requirements for current good manufacturing practices.
The second document, “Donor Eligibility for Animal Cells, Tissues, and Cell- and Tissue-Based Products,” assists organizations or individuals that participate in the manufacture of ACTPs or perform any aspect of ACTP donor eligibility determination by providing the Center for Veterinary Medicine’s recommendations on screening, testing, and selecting appropriate donors.
The FDA CVM explained in the guidance document that “ACTPs that are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or are intended to affect the structure or function of the animal generally meet the definition of a new animal drug.”
All new animal drugs, including ACTPs, have to meet the requirements of the Federal Food, Drug, and Cosmetic Act regarding safety and must have the identity, strength, quality, and purity characteristics that they claim—which is why donor eligibility is critical to ensuring safety and quality when manufacturing ACTPs, the CVM explained.
The webinar will remain available as a resource for developers of ACTPs. Stakeholders can submit questions to FDA-CVM-Animal-Biotechnology-Feedback@fda.hhs.gov. More information from the FDA on ACTPs is available at the FDA website.
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