Roche developed MycoTOOL PCR (polymerase chain reaction) assays as a faster alternative to culture-based detection of Mycoplasma or Mollicutes bacterial contamination. The tool launched in 2009 and will now also be sold, and used in contract services, by Lonza.
Robert Yates, head of Roche Applied Science, said: “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.”
Traditionally culture-based techniques are used to detect Mycoplasma or Mollicutes contamination in biologics production. However, these techniques take 28-days.
In 2007 the European Pharmacopeia accepted real-time PCR as an alternative to traditional Mycoplasma detection and companies, including Roche, have responded with new products.
The European Medicines Agency (EMA) approved MycoTOOL for release testing of a Roche product in July 2009. Since then the EMA has approved the test for other pharmaceutical products.
Selling kits and offering testing services makes Lonza a provider and consumer of pharma quality control products. Roche is another of a small pool of companies in this position and, said Lukas Utiger, head of Lonza BioSciences, this gives the distribution partners a novel perspective.
“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”, said Utiger.