BioOutsource — cGMP compliant biotesting
in vitro Assays
Cell based in vitro assays are some of the most widely used tests to detect the presence of adventitious viruses. Guidelines since the advent of biotechnology products have required the use of in vitro assays for the presence of adventitious viruses; these assays have been based on those used for the release of viral vaccines. Gene therapy vectors including Retrovirus, Adenovirus and Dependovirus vectors also require safety testing using cell based assays to evaluate the presence of not only adventitious viruses but also to ensure there is no replication competent virus present in the drug product.
BioOutsource can provide cGMP compliant testing for batch release of Viral Vaccines, Gene Therapy and other products. Detector cell lines (Human, Primate and Rodent) have been banked and characterised and controlled by cGMP
