Cell and Gene Therapy Product Manufacturing Considerations

FDA has published an immediately effective guidance, Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During Covid-19 Public Health Emergency, to give manufacturers of such products risk-based recommendations to minimize potential transmission of the SARS-CoV-2 novel coronavirus. The document is intended to supplement a 6/2020 Good Manufacturing Practice guidance. The recommendations specifically consider the source material (cells and/or tissues) recovered from donors and how the cellular therapy and gene therapy (CGT) product will be manufactured (e.g. cell expansion in culture, viral reduction steps, formulation), FDA says.

The scope of the guidance applies to CGT products regulated by CBER as biological products or drugs under specified laws. It does not apply to those human cells, tissues, and cellular- or tissue-based products regulated solely under other sections of the law or regulated as medical devices.