BioOutsource

Service Profile

We offer an efficient, client focused service in the areas of product characterisation and release testing including cell based potency assays, virus screening assays, molecular biology and protein characterisation. In addition to batch release testing, we support assays for clinical trial analysis including anti drug antibody determination and residual DNA. Our strengths are our staff’s scientific expertise coupled with an unprecedented level of study transparency using an innovative client interactive IT system that will allow us to offer an unparalleled high quality service. The BioOutsource team have an in depth experience of batch release testing with recombinant proteins, monoclonal antibodies, fusion proteins, gene therapy vectors, virus vaccines and cell based therapies.

Drug Specifications

A specification is defined as a list of tests, references to analytical procedures and biological products to support marketing authorisation. Specifications will set the criteria to which a drug substance or drug product will conform to be considered to be acceptable for its intended use. Generally the following tests are applicable to all drug substances, BioOutsource can support our clients with these tests to cGMP.

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