Roche and Lonza in distribution agreement for rapid mycoplasma
20 April 2011
Swiss companies Roche and Lonza 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 is the first commercial NAT-based detection system
that is used for mycoplasma biosafety testing of approved biological
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
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
“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.