Lonza & Roche ink bacteria detection kit deal

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Lonza is selling MycoTOOL detection kits for final release testing after inking a distribution agreement with Roche.

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.

Unique perspective

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.

Related topics: Processing, QA/QC

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