First Commercially-Available Mycoplasma Detection Test Accepted by FDA - - BioPharm International

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First Commercially-Available Mycoplasma Detection Test Accepted by FDA


Pharmaceutical Technology Europe

Roche's MycoTOOL, which offers rapid detection of mycoplasms based on a polymerase chain reaction (PCR) test, has received FDA acceptance. This is the first commercially-available Mycoplasma PCR test accepted by the FDA for the release testing of a biopharmaceutical product that can replace traditional and time-consuming Mycoplasma detection assays which use growth on culture media and in vitro assays to detect contaminating organisms.

Mycoplasma contamination is a common and significant issue in biopharmaceutical production, cell therapy, tissue engineering, and vaccine manufacturing. The conventional culture-based detection methods required by pharmacopoeias and drug-regulating agencies are time-consuming as they can take as much as 28 days to complete, making them laborious and difficult to interpret. Ruedi Stoffel, head of custom biotech at Roche, said in a press statement, "Fast methods, like our new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the manufacturing process of pharmaceutical and biological products."

The MycoTOOL PCR Mycoplasma detection kit provides all critical reagents for performing sample preparation and PCR. The tool is compatible with a range of sample types, including cellular matrices (human cells, primary and continuous), canine cells, nonhuman primate cells, various rodent cell types, and cell-free matrices (culture supernatants of CHO or human-stem cells, and egg-derived samples). It also detects the broad panel of Mollicute species. The test minimizes the risk of false negative and false positive test results. The risk of undetected intracellular Mycoplasma is eliminated by lysis controls of the matrix while positive controls verify potential PCR inhibition. Nucleic acid free reagents prevent false positives, and the use of uracil-DNA glycosylase minimizes the risk of PCR carryover contamination.

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