Using rapid microbiological methods to ensure product safety

Testing short-life cell and gene therapeutics for microbiological contamination is a challenge because they usually need to be administered before the result of a compendial sterility test becomes available. This is why manufacturers are implementing alternative rapid methods that take only a fraction of the time.

USP <1071> gives an overview of several rapid technologies deemed suitable for release testing of sterile short-life products, including ATP bioluminescence, nucleic acid amplification, respiration, and solid phase cytometry. In this article, two experts on rapid microbial technologies — Estelle Alvergnas and Lamin Jallow — discuss how flexible rapid testing can serve the different needs of advanced therapy manufacturers.

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This article was originally published in American Pharmaceutical Review.