Sterility is a critical quality attribute (CQA) of cellular therapeutics. Since microbial contamination of cell therapy products can potentially result in patient deaths, sterility testing is an essential component of release testing for cell therapy products.
Current compendial sterility testing takes 14 days before contamination can be ruled out with certainty, which is too long for short shelf-life cellular therapeutics - especially autologous cell therapies intended to treat terminally ill patients. As a result, there is an increasing demand for growth-independent rapid assays.
To meet this important demand, a detection system consisting of the highly efficient DNA extraction protocol Microsart® ATMP Extraction - followed by the real-time PCR assay Microsart® ATMP Bacteria - has been developed.
In this poster, a validation study was designed to evaluate bacterial and fungal detection capability. The study was set up to fulfill the European Pharmacopeia chapter 5.1.6 and USP chapter <1223> as well as the guidance chapter USP <1071>.
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