Manufacturing Considerations for Cell and Gene Therapies During COVID-19

FDA published guidance for industry on Jan. 19, 2021 to provide manufacturers of cell and gene therapies (CGT) with risk-based recommendations for minimizing the potential transmission of COVID-19.The guidance supplements a previous guidance document published in June 2020.

The guidance discusses source materials from donors, including cells and/or tissues. It also discusses cell expansion in culture, viral reduction steps, and formulation. “In light of SARS-CoV-2, FDA recommends that CGT product manufacturers perform a risk assessment that identifies, evaluates, and mitigates factors that may allow for transmission of SARS-CoV-2 by CGT products. A description of the risk assessment and mitigation strategies should be included in the appropriate submission to FDA (e.g., investigational new drug application [IND], biologics license application [BLA], or master file),” FDA states in the guidance document.