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qPCR (nucleic acid) based sterility testing – The release test for sterility in medical applications is prescribed in chapters EP 2.6.1 (Sterility) and 2.6.27 (Cell based preparations). Especially with short-lived products such as ATMPs growth-based methods are clearly too slow. In addition, non-cultivable microorganisms can easily be overlooked. We are currently implementing an alternative nucleic acid amplification-based method for fast and safe testing of your samples.

Learn more about Sterility Testing.