FDA allows Mycoplasma release testing of a biopharmaceutical product using MycoTOOL®
In November 2012, the US Food and Drug Administration accepted the use of the MycoTOOL® PCR Mycoplasma Detection Kit as a release method for a biopharmaceutical product manufactured by Roche Applied Science intended for distribution in the United States.
This decision from the FDA marks one of the first approvals by the agency for the use of a commercially-available, PCR-based mycoplasma detection kit as a total replacement for the traditional, 28 day culture-based mycoplasma detection method currently endorsed by global regulators.
“Mycoplasma contamination represents a significant issue during biological drug production,” explains 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.”
Lonza distributes the MycoTOOL® PCR Mycoplasma Detection Kit from Roche under a co-exclusive agreement and offers rapid mycoplasma testing services using this method.
“We are thrilled to hear about the FDA’s decision to accept Roche’s drug application using MycoTOOL® as an alternative release method for mycoplasma detection. Shorter product release times will certainly help to reduce costs for inventory hold time and prolong product shelf life,” says Lukas Utiger, Head of Lonza Bioscience Products (LBSP).
The MycoTOOL® PCR Mycoplasma Detection kit was developed by Roche Custom Biotech to help reduce the turnaround time for mycoplasma safety release testing in their quality control process. Release testing using the MycoTOOL® Kit was previously approved by the European Medicines Agency (EMA) for several pharmaceutical products manufactured by Roche Applied Science, making it the first commercially available mycoplasma PCR test used to replace traditional mycoplasma tests (cell-dependent and cell-independent methods) during pharmaceutical production. Developed and manufactured within a regulated environment, the product design, production process, change control notification procedure, premium quality raw materials, logistics, and fulfillment systems help ensure that the kit retains its proven high quality.