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In vitro Services

ViruSure’s Tech Gate facility has been established with the goal of providing high quality in vitro testing for biopharmaceutical products. A strict segregation concept together with full ICH compliant assay validation ensures trustworthy test results. All tests are performed as standard with appropriate matrix interference controls where necessary. A range of in vitro tests are offered by ViruSure as summarised below:

Cell Bank and Virus Seed Characterisation

Adventitious agent testing plays an important role in the lot release of recombinant biopharmaceutical and vaccine products and is required at the following stages of biopharmaceutical product development and production:

  • Master and Working cell banks and End of Production cell banks
  • Master virus seed banks
  • Production lot release
qPCR Tests for Virus Contaminants

For certain viruses, detection in cell based infectivity systems has remained challenging,and for these viruses qPCR often offers the only viable test system for detection. ViruSure is able to offer a range of qPCR tests for common virus contaminants including Mice minute virus (MMV),Porcine circovirus (PCV1 and PCV2), Vesivirus 2117 and many others. A full list of available tests can be provided on request.

Testing of Animal Derived Products and Recombinant Products for Virus Contamination

The term in vitro testing is applicable both to tests performed on the production material as well as to the testing of raw materials. For example, guidelines have been established in both Europe and the US FDA for the testing of bovine serum prior to use in manufacture. This includes tests on permissive bovine cell lines with specific end point detection for Bovine adenovirus, Bovine parvovirus, BRSV, Reovirus, Bovine paramyxovirus, Infectious bovine rhinotracheitis virus and Bluetongue virus. Similar tests are available for Porcine derived contaminants. Please contact us for more details of available tests for animal derived component at ViruSure.

Virusure GmbH

Donau-City-Straße 1, A-1220 Vienna, Austria.
Phone: +43-(0)1-2699120
Fax: +43-(0)1-2699120/22