FDA is issuing this guidance to provide manufacturers of licensed and investigational cellular therapy and gene therapy (CGT) products with risk-based recommendations to minimize potential transmission of the novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This guidance is intended to supplement the recommendations to drug and biological product manufacturers provided in FDA’s “Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing; Guidance for Industry” issued in June 2020 (Ref. 1) (June 2020 GMP Guidance). The recommendations in this guidance specifically consider the source material (cells and/or tissues) recovered from donors and how the CGT product will be manufactured (e.g., cell expansion in culture, viral reduction steps, formulation).
The scope of this guidance applies to CGT products regulated by FDA, Center for Biologics Evaluation and Research (CBER) as biological products under section 351(i) of the Public Health Service Act (PHS Act) (42 U.S.C. 262) and as drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355).1 This guidance does not apply to those human cells, tissues, and cellular- or tissue-based products (HCT/Ps) regulated solely under section 361 of the PHS Act (42 U.S.C. 264), as described in Title 21 of the Code of Federal Regulations (CFR) Part 1271 (21 CFR Part 1271), or regulated as medical devices under the FD&C Act.
There is currently an outbreak of respiratory disease caused by a novel coronavirus. The virus has been named “SARS-CoV-2” and the disease it causes has been named COVID-19. On January 31, 2020, HHS issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.
Respiratory viruses, in general, are not known to be transmitted by implantation, transplantation, infusion, or transfer of HCT/Ps. FDA is not aware of any CGT products that have been contaminated with SARS-CoV-2 or of information indicating transmission of SARS-CoV-2 via these products. However, as noted in FDA’s June 2020 GMP Guidance, (Ref. 1), SARS-CoV-2 is a novel coronavirus and, to ensure compliance with current good manufacturing practice (CGMP) requirements, CGT manufacturers are expected to evaluate whether it poses new risks in the context of their specific products, facilities, processes, and manufacturing controls. FDA also posted COVID-19 considerations for HCT/P establishments in general. 4 Additional concerns specific to establishments that manufacture CGT products may involve the potential for the unintended expansion of SARS-CoV-2 in autologous or allogeneic infected cells or tissues during the manufacturing process (e.g., during cell culture) resulting in a final product with amplified SARS-CoV-2 viral load.
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