A Rapid Alternative To Culture-Based Mycoplasma Detection

Per regulatory requirements, cell-culture based therapies must be free of mycoplasma. Manufacturers have traditionally outsourced testing to labs that specialize in the 28-day culture-based test method. For manufacturers of gene and cell therapy products, as well as other low-dose and short shelf-life therapeutics, it is not feasible to wait 28 days for test results. Thus, the need for rapid mycoplasma test results has also increased. Real-time PCR based assays provide a viable alternative to the culture based method and provide results in hours while meeting the required sensitivity. Following validation, regulatory filing and review, users across multiple therapeutic modalities have received regulatory acceptance to use the Applied Biosystems™ MycoSEQ™ Mycoplasma Detection assay for lot release testing.

This poster describes the MycoSEQ assay, an accurate and sensitive real-time PCR mycoplasma detection assay that provides results in under 5 hours. Additionally, we present 2 case studies from users who have validated and received regulatory approval to use the assay for product lot release.