Demonstrating the absence of mycoplasma at specified points in manufacturing is a regulatory safety requirement for most vaccines and cell-derived therapeutics because of the risk of bacterial infection to patients.
Traditional microbiological techniques have many disadvantages known to the industry. These techniques are labor-intensive, take 28 days, require growing live mycoplasma, and are difficult to interpret, making them especially unsuited for cell and gene therapies. Regulatory agencies accept nucleic acid amplification tests (PCR) as an alternative method for mycoplasma detection after proper validation.
Based on more than a decade of mycoplasma testing innovation, Roche CustomBiotech addresses the limitations of traditional testing methods with the MycoTOOL PCR-based mycoplasma testing systems. Our MycoTOOL methods are employed by numerous therapeutics manufacturers, including Roche Pharmaceuticals/ Genentech, for the release of select clinical and commercial biologics.
Here is a quick summary of the Roche CustomBiotech MycoTOOL innovation story.
The MycoTOOL PCR mycoplasma detection kit based on endpoint PCR was developed as a joint effort between Roche Pharmaceuticals and Genentech. Both were looking for a rapid, PCR-based method to replace the time-consuming cell culture test for mycoplasma.
This first MycoTOOL endpoint PCR kit was made commercially available.
The method validation for the MycoTOOL endpoint PCR kit was published
A critical milestone was achieved when Roche Pharmaceuticals gained regulators acceptance with the MycoTOOL endpoint PCR kit as a release test for one of their biopharmaceutical products. At the same time, Roche CustomBiotech launched the MycoTOOL Real-Time PCR kit, which is now used by Roche Pharmadeuticals for in-process testing and for release of newer biopharmaceuticals.
Roche created a validation report for the MycoTOOL Mycoplasma Real-Time PCR kit to support manufacturers in their own product-specific validations.
Roche Pharmaceuticals gained FDA acceptance using the MycoTOOL Mycoplasma Real-Time PCR kit as a release test for one of their commercial biopharmaceutical products. The fact that these kits are also used internally by Roche Pharmaceuticals demonstrates our confidence in the product performance.