Roche unveils MycoTOOL Real-Time PCR Kit validation report for improved quality control of biopharmaceutical products

Rotkreuz, 18 December 2014

Roche today announced the global availability of the validation report for the MycoTOOL Real-Time PCR Kit, now validated by the Roche Pharma division. The report helps customers to decide which quality control and validation strategy to use with their applications when using the MycoTOOL Real-Time PCR Kit, regardless of whether CHO (Chinese hamster ovary) cells or other cell types are used.

The MycoTOOL Real-Time PCR Kit is a mycoplasma test that reduces testing time to hours instead of days and can be used to replace the cell culture assay. Based on real-time PCR technology, this test helps improve efficiency and quality in the manufacturing process. Introduced in 2012, the real-time kit is the follow-up to the MycoTOOL PCR Mycoplasma Detection kit, which has been accepted as a release test in more than 150 countries and is used by the Roche Pharma division on a routine basis.

The MycoTOOL Real-Time PCR Kit has been developed to meet the requirements of the European Pharmacopeia EP 2.6.7. Roche is planning additional tests for residual DNA and has other portfolio expansions currently underway.

About mycoplasmas

Mycoplasmas belong to the bacteria class of Mollicutes and are a common source of contamination in biopharmaceutical processing. Traditional tests lack accuracy, because some bacteria in this class are hard to cultivate. Current test methods are cumbersome, requiring cell cultures that take 28 days. PCR tests reduce this time to a few hours only.

About Custom Biotech

For thirty years now, Roche Custom Biotech has been manufacturing industrial chemistry and supplying a range of customers, particularly in the diagnostics industry. Our team offers products and solutions for manufacturers in the diagnostics and pharma biotech industry, ranging from raw materials to system solutions for bioprocessing. Customers benefit from our strong customization skills at any scale or production stage, as well as contract manufacturing services.  Roche Custom Biotech is committed to the mission of improving the quality of healthcare. Our expanding pharma product portfolio, including Recombinant Trypsin and Liberase Enzyme Blends, is manufactured under GMP regulations in order to meet the exacting demands of pharmaceutical manufacturers.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the WHO Model Lists of Essential Medicines, among them life-saving antibiotics, anti-malarials and chemotherapy.

In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit

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