Mycoplasma Detection

Rapid Mycoplasma testing for lot-release and in-process testing

Mycoplasmas—the smallest known free-living organisms—are difficult-to-detect bacterial contaminants in mammalian cell cultures. In therapeutic applications, an undetected Mycoplasma contamination can negatively impact product quality and patient safety. Manufacturers following cGMP guidelines develop stringent risk mitigation plans to ensure early detection of Mycoplasmas to avoid costly manufacturing delay or remediation activities. For lot-release testing, many regulatory bodies require that all products derived from mammalian cell culture be tested for the presence of Mycoplasma.