PENZBERG, Germany--(BUSINESS WIRE)-- Roche (SIX: RO, ROG; OTCQX: RHHBY) and Lonza announced today that they have entered into a co-exclusive distribution agreement for the commercialization of Roche’s MycoTOOL mycoplasma PCR assays. MycoTOOL detection kits are now available through Lonza for final release testing of pharmaceutical products, upon validation. Additionally, Lonza offers contract testing services using the MycoTOOL test. MycoTOOL test is the first commercial NAT-based detection system that is used for mycoplasma biosafety testing of approved biological products.
Release testing with the MycoTOOL PCR-test from Roche Custom Biotech, a part of Roche Applied Science has been approved by the European Medicines Agency (EMA) for several pharmaceutical products. It is the first commercially available mycoplasma PCR-test that is used to replace traditional mycoplasma tests (cell-dependent and cell-independent culture methods) during pharmaceutical production. Developed and manufactured within a regulated environment, the product design, production process, change control notification procedure, premium quality products, logistics, and fulfilment systems help ensure that the products retain their proven high quality.
Robert Yates, Head of Roche Applied Science, commented: “Lonza’s reputation for quality and customer care gives us confidence that MycoTOOL will be placed in the right applications for customers who wish to perform rapid mycoplasma testing in-house, and for those who prefer to send their samples to a qualified outside laboratory for testing.”
“Roche and Lonza share the rare combination of being both consumers and providers of pharmaceutical quality control and diagnostics products. This internal integration of user and manufacturer helps ensure products align properly with user requirements and capabilities. The unique perspective of being a user of the very products you sell provides insight unattainable from the outside looking in. We are pleased to be working with Roche in bringing this advancement to our colleagues,” said Lukas Utiger, Head of Lonza BioSciences.
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, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
Lonza is one of the world's leading suppliers to the pharmaceutical, healthcare and life science industries. Products and services span its customers’ needs from research to final product manufacture. It is the global leader in the production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. Biopharmaceuticals are one of the key growth drivers of the pharmaceutical and biotechnology industries. Lonza has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. In addition, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing. Furthermore, the company is a leading provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. Lonza is headquartered in Basel, Switzerland and is listed on the SIX Swiss Exchange. In 2010, the company had sales of CHF 2.680 billion. Further information can be found at www.lonza.com.
For use in quality control/manufacturing process only.
MYCOTOOL is a trademark of Roche.
Other brands or product names are trademarks of their respective holders.
Dr. Burkhard Ziebolz
Phone: +49 8856 604830
Email: [email protected]
KEYWORDS: United States Europe North America Germany
INDUSTRY KEYWORDS: Health Medical Devices Oncology Pharmaceutical Medical Supplies