BioOutsource

Bioassay Development

Choosing the right partner for the development and operation of one of these assays is critical. BioOutsource scientists have a wealth of experience in a number of techniques and can advise on the best route for developing an assay, specific for your product.

During proof of concept studies, we can develop new methods or adapt discovery-based assays by applying in-house expertise to generate robust methods. Using statistical-based approaches, we are able to determine the most appropriate assay design, capable of meeting the rigorous demands of regulatory acceptance, whilst reducing the cost and timelines associated with the testing of your product. During this period, we are able to generate qualified, GMP-compliant cell banks, establish criteria for critical reagents and define the specifications of the Reference Standard that will enable a measure of relative potency.