Virus Product Testing
BioOutsource is the industry leading expert in the characterisation of virus vaccines, virus vector and oncolytic vaccine products. We have created a niche within the vaccine industry, dedicating ourselves to the biological evaluation of therapeutic virus products, offering a comprehensive range of off-the-shelf testing methodologies to support biosafety & lot release testing. With years of experience in the performance of these assays coupled with off-the-shelf methods, we provide comprehensive expertise to reduce the both the time and cost of your vaccine development programmes.
Attenuated viruses can be used to derive vaccines for humans and commercially important animals. BioOutsource has experience of many Human virus vaccines including influenza, measles, mumps, rubella, hepatitis viruses (A and B) , polioviruses, poxviruses, rotaviruses, flaviviruses (including dengue virus, japanese encephalitis virus and yellow fever virus).
Guidance and regulation for the derivation, characterization and biosafety testing of human vaccines from the US FDA and WHO includes ‘Characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications’ and Biologicals and Vaccine Standardization where useful monographs can be found. The Pharmacopoeias also have detailed requirements, for example European Pharmacopoeia 5.2.3. Cell substrates for production of vaccines for human use. The production and safety testing of veterinary vaccines are also regulated stringently and guidance is provided by the World Organisation for Animal Health Principles of veterinary vaccine production and the European Pharmacopoeia 5.2.4. Cell cultures for the production of veterinary vaccines. The biosafety tests for vaccine and virus products fall into the following stages:
- Cells at limit
- Master Virus Seed Stock
- Virus Bulk Harvest
- Purified Bulk Harvest
- Filled Viral Vaccine
- Virus and Vector Shedding
Contact our experts to discuss your vaccine testing requirements.