Roche’s Rapid Mycoplasma Detection Test MycoTOOL Receives Acceptance from Canadian Authorities for Release Testing of Biopharmaceutical Roche Product
13 Jun 2013
Roche announced that the Canadian Health Authority has accepted the use of its PCR based mycoplasma detection test MycoTOOL for release testing of one of Roche’s biological products. The test can replace conventional and time-consuming mycoplasma detection assays based on culture methods and was also accepted by the FDA end of last year.
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,” commented 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.”
A lecture about the MycoTOOl test will be offered at the Rapid Microbiological Methods Conference taking place on 11 and 12 December 2013 in Munich.
About the MycoTOOL PCR Mycoplasma Detection Kit
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.
For use in quality control/manufacturing process only.
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MycoTOOL PCR Mycoplasma Detection Kit
RocheMycoTOOL PCR Mycoplasma Detection Kit - Highly sensitive PCR test for the detection of Mycoplasmas. Mycoplasmas are frequent causes of contamination in biopharmaceutical production, cell therapy and tissue engineering. Traditional detection methods, use growth on culture media to detect contaminating organisms. These culture-based methods are time-consuming, requiring as much as 28 days to complete, laborious and difficult to interpret. Rapid methods, like the new MycoTOOL Test for detecting Mycoplasma contamination, can help improve efficiency, quality and safety in the manufacturing of pharmaceutical and biological products. Use the MycoTOOL test in the field of biopharmaceutical and vaccine production, cell therapy, transplantation, and veterinary testing. MycoTOOL PCR Mycoplasma Detection Kit is accepted for release testing of biopharmaceutical products by FDA, EMA and authorities in several other countries for fast, easy, and reliable Mycoplasma testing. MycoTOOL PCR Mycoplasma Detection Kit Features: Save time. Replace traditional 28 days culture testing with the rapid MycoTOOL PCR Test. Speed up your validation. Rely on published Roche validation data (see Literature). Detect traces of Mycoplasmas. The sensitivity is 1 CFU/ml. Minimize the risk of false negatives and false positives. The matrix lysis control eliminates risk of undetected intracellular Mycoplasma. The diluted GAPDH and positive control identify potential PCR inhibition. False positives are prevented by nucleic acid free reagents, tested according to Roche's current ultrasensitive Quality Control procedures. Uracil-DNA Glycosylase pretreatment is performed to prevent contamination by PCR carryover. Detect the broad panel of Mollicute species. A universal primer design covers a whole range of Mycoplasmas. Achieve process security. Rely on test results using a consistent kit quality and established change control procedures.