First rapid final release test of ATMPs prior to treatment—validation of a robust and highly sensitive qPCR test for total bacteria

      Contaminated ATMPs pose life-threatening risks for potential patients who are very often immunocompromised. A reliable microbial release test that can be used prior to treatment is therefore critical to ensuring patient safety. Current international pharmacopeia stipulate a 14 day sterility test period. Typically, ATMPs have a shelf-life of less than 48 hours. Hence, traditional methods cannot be used for release testing of ATMPs prior to treatment. The risk of administering potentially contaminated ATMPs to patients urges both industry and authorities to find solutions for rapid release testing.
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