USP Mulls Rapid Sterility Testing Standards For Cell Therapies, PET Drugs And Sterile Compounding
USP is looking to develop standards for rapid sterility tests for drugs and biologics. Existing growth-based compendial methods are too slow to obtain results before cell and gene therapies, positron emission tomography drugs and sterile compounded drugs must be used. Quicker methods would improve efficiency in the manufacture of other drugs as well. Detection limits could be orders of magnitude higher without compromising the ability to detect infectious levels of microbiological organisms.
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For short-lived cell and gene therapies that must be given to patients before traditional sterility testing results can be obtained, the question is whether less sensitive rapid tests that can be completed in advance might be a better choice. Should manufacturers demonstrate a lack of viable microorganisms, or is it OK merely to show there aren’t enough of them to produce an “infectious dose”?
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