Regulators require that cell culture-based bioprocesses used for manufacturing of protein therapeutics, vaccines, and cell and gene therapy products be tested for the presence of mycoplasma. Rapid detection kits provide a welcome alternative to the 28-day culture-based test which are expensive and time-consuming, and empower companies to rapidly test for mycoplasma in raw materials and in-process screening.
The ultimate goal of any company using a rapid qPCR mycoplasma detection kit is to validate their method and comply with FDA regulations for lot-release of the drug product. A closer look reveals there are several key features that, in addition to effective risk-mitigation tools, are important considerations to plan for validation and regulatory acceptance of a mycoplasma testing method.
