Roche said this week that the US Food and Drug Administration has accepted the use of its PCR-based mycoplasma detection test for release testing of an undisclosed Roche biopharmaceutical product.
Roche said the test, called MycoTool is the first commercially available mycoplasma PCR test accepted by the FDA for release testing of a biopharmaceutical product. A Roche spokesperson said that acceptance of such a test is directly and exclusively related to release testing of a specific pharmaceutical product.
Mycoplasms frequently cause 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.
Such tests, Roche said, require as many as 28 days to complete and are laborious and difficult to interpret. MycoTool, on the other hand, takes approximately one day to complete. MycoTool also provides all reagents for sample preparation and PCR; has a sensitivity of less than 1 CFU/mL for most isolates; and is compatible with a diverse spectrum of sample types including cellular matrices, canine cells, non-human primate cells, many different rodent cell types, and cell-free matrices, such as culture supernatants of CHO or human stem cells and egg-derived samples. The assay detects more than 150 species due to its universal primer design.
The test also minimizes the risk of false negative and false positive test results, as 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, while uracil-DNA glycosylase minimizes the risk of PCR carryover contamination.
In April 2011, Swiss pharmaceutical products and services firm Lonza became the distributor of MycoTool under a co-exclusive agreement between the companies.