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Is Your Cell and Gene Therapy Manufacturing at Risk for SARS-CoV-2?

New FDA guidance recommends evaluating process and product for transmission potential. 

Though respiratory viruses such as SARS-CoV-2 are not known to be transmitted by implantation, transplantation, infusion, or transfer – i.e., the common route of administration for cellular and gene therapies – there is much about the novel coronavirus that is unclear. We do know, however, that SARS-CoV-2 has been shown to infect and replicate in cells commonly used in vector production. For developers of cellular and gene therapies that use vector delivery, this poses a risk to product quality and patient safety.

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The FDA Weighs In

The ongoing COVID-19 public health crisis has made it clear that we must be extra vigilant for sources of risk. In response, the FDA has released a new guidance document for the manufacturers of licensed and investigational cellular therapy and gene therapy (CGT) products to minimize potential transmission of SARS-CoV-2.  This guidance is specific to source material (cells and/or tissues) recovered from donors and how the CGT products will be manufactured and offers points to consider when evaluating their manufacturing process and source materials for potential contamination.  This new guidance supplements 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). 


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Guidance Summary

To mitigate risk in product manufacturing, the FDA recommends that you:

  • Review your facility and equipment cleaning and sanitation and other controls to ensure your materials, active pharmaceutical ingredients, components, in-process materials, drug product containers and closures are safe
  • Identify and evaluates factors that may allow for transmission of SARS-CoV-2 by CGT products and address these risks
  • Include a summary of your assessment and mitigation procedures in your submissions to the FDA as required
  • Prevent and minimize any potential adverse effects on the safety and quality of your products

A thorough risk assessment should include evaluation of:

  • Donors, to determine and document eligibility of donor cells and/or tissues
  • Cellular/tissue source material, considering its specific organ system and the known ability of SARS-CoV-2 to infect and replicate in source material
  • Manufacturing, with focus on materials and processes used to control viral spread and contamination risk
  • Materials, ensuring production controls and changes are approved per cGMP requirements

Are You Prepared to Address These Recommendations?

Whether you’re working on vaccines, antivirals, immuno-modulators, antibody therapies, or equipment, your program has unique requirements and needs. As your partner in development, we’ll keep your program on track with leading scientific and regulatory expertise and a robust portfolio of models, screening, products, and services.

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