Mycoplasma Detection Assays

Mycoplasmas, the smallest known free-living organisms, are bacterial contaminants of mammalian cell cultures. Regulatory guidance requires that all products derived from mammalian cell culture be tested for Mycoplasma.

The evaluation and selection of a rapid mycoplasma detection method, as an alternative to the standard culture method, should include assessment of comparability, including attributes such as specificity, limit of detection, sample volume, assay performance monitoring. In addition, the suitability of the method for the sample type should be evaluated. A risk assessment for the introduction and detection of a mycoplasma contamination should be performed to ensure replacement of the culture assay does not result in an unforeseen increased risk profile.