For my CMC collegues working with allogenic cell therapies this will be of interest.
The Introduction notes "Cell safety testing should be based on a risk analysis (emphasis mine) that considers the expansion potential of the cells, the reagents that are used to expand the cells in culture, and the number of individuals the cell-based medical product is capable of treating".
From the Scope:
"This guidance applies to allogeneic cell-based products that are regulated by the Office of Therapeutic Products of the Center for Biologics Evaluation and Research (CBER) under section 351 of the Public Health Service Act (42 U.S.C. 262). This guidance applies to cultured allogeneic cells, including cell banks, that are sources of the intended constituents of the final drug product, as well as combination products that contain an allogeneic cell or cell-based biologic constituent part in combination with a drug and/or device. The recommendations in this guidance also apply to genetically modified allogeneic cells that have been transduced with viral and/or plasmid vectors, and cells that have undergone genome editing. This guidance does not apply to cell substrates that are used during manufacturing of non-cell-based products such as viruses, gene therapy vectors, or recombinant proteins. Recommendations for feeder or other cells used as reagents during manufacturing are beyond the scope of this guidance."
https://www.fda.gov/media/178113/download
#fda #DraftGuidance #celltherapy#allogenic
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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