BioOutsource is the leading company for the testing of viruses and gene therapy vectors for clinical trials. We have created a niche within the vaccine industry, dedicating ourselves to the safety testing and biological evaluation of virus products. We offer a comprehensive range of off-the-shelf biosafety testing methodologies to support both Biosafety and Clinical support. Our team has many years of experience in the performance of assays for a variety of different viruses, coupled with off-the-shelf methods, we provide comprehensive expertise to reduce both the time and cost of your virus development programmes.
At the core of Biosafety testing are the guidelines from both the European Pharmacopoeia and the United States FDA. Since many viral vaccine and gene therapy products, by their nature, do not undergo extensive purification or virus inactivation procedures, the testing is particularly stringent. Therefore, where as it may be permissible to have detectable infectious retrovirus in cells used to produce monoclonal antibodies or extensively purified biologics it is not permissible in cells used to produce virus vaccines or gene therapy vectors. Furthermore, there are still a number of vaccines, including seasonal influenza virus, that are produced on primary cells which cannot be banked and extensively characterised before use as production substrates and as such the testing strategy and emphasis on testing will differ from that of a product made in a WCB.
A further complication relates to the ability of the viral products to interfere with normal adventitious agent testing particularly in vitro cell based tests and in vivo tests. Even when the test virus can be neutralised or partially neutralised using antisera there are still problems with toxicity of the neutralised virus and breakthrough of the virus product. BioOutsource have solved this problem with our unique Neutralising Antiserum service.
The Biosafety tests for vaccine and virus products fall into three parts:
- Seed Virus Testing
- Cell Bank Characterisation
- Virus Product Testing