Reduce release risk for short-shelf-life cell therapies with 5-hour sterility testing

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For short-shelf-life cell therapies, waiting up to 14 days for sterility results can create real release and logistics challenges. This application note highlights a qPCR-based approach that detected the six USP <71> organisms in complex cell therapy matrices in 5 hours. It also includes data supporting a centrifugation step to help reduce signal from DNA released by lysed microbes, improving confidence in rapid sterility testing workflows.

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