FDA Clearance of Rapid Mycoplasma Detection Test from Roche

Today Roche announced that the U.S. Food and Drug Administration (FDA) has accepted the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of Roche’s biological products. It is the first commercially available mycoplasma PCR test accepted by the FDA for release testing of a biopharmaceutical product that can replace conventional and time-consuming mycoplasma detection assays based on culture methods.

Mycoplasms are frequent causes of contamination in biopharmaceutical production, cell therapy, tissue engineering and vaccine manufacturing. Traditional detection methods, required by Pharmacopoeias and drug regulating agencies worldwide, use growth on culture media and in vitro assays to detect contaminating organisms. Requiring as much as 28 days to complete, these growth-based methods are time-consuming, making them laborious and difficult to interpret.

“Mycoplasma contamination represents a significant issue during biological drug production,” said Ruedi Stoffel, Head of Custom Biotech at Roche. “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 an easy to use sample preparation and PCR. It offers a high sensitivity (<1 CFU/ml for most isolates) and is compatible with a diverse spectrum of sample types as cellular matrices (Human cells, primary and continuous), canine cells, nonhuman primate cells, many different rodent cell types and cell-free matrices (culture supernatants of CHO or human stem cells, egg derived samples). It detects the broad panel of Mollicute species too, including over 150 species due to universal primer design (e.g. Mycoplasma, Spiroplasma, and Acholeplasma).

The test also minimizes the risk of false negative and false positive test results: lysis controls of the matrix eliminate the risk of undetected intracellular Mycoplasma and positive controls verify potential PCR inhibition. Nucleic acid free reagents also prevent false positives and the use of uracil-DNA glycosylase minimizes the risk of PCR carryover contamination.