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GMP Biosafety Testing

If you have a specialized product, perhaps produced in an unusual cell line or which is introducing a technology not previously the subject of intensive study in humans, then the panel of tests may need to be custom developed in order to ensure that all potential risks are adequately addressed. The experience available within ViruSure covers a wide range of test development including:

  • Quantitative real-time PCR assays
  • Retrovirus assays
  • Cell culture based assays
  • In vivo tests
  • Immunological assays

Developing the best test strategy for products which presents new concepts or new technologies to regulatory authorities can be a challenge. It requires an in depth knowledge of the system worked with, the potential risks that might exist, as well as the issues most likely to receive intense scrutiny by the regulatory agencies. At ViruSure, we will work with you to identify a sound and cost effective strategy, if necessary assist you with discussions about your product with the regulatory agencies. Ensuring that your pathogen safety testing strategy has the highest chance of success- is one of our prime objectives.

Some examples of products likely to require custom designed assays or pathogen safety strategies are detailed below:

  • Gene therapy vectors (e.g. tests for replication competent viruses)
  • Animal derived products
  • Vaccines (live vaccines can often present a challenge for pathogen safety tests due to the presence of live virus)
  • New technologies or systems not previously tested in humans or animals
  • Cell based therapies

Virusure GmbH

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

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