Bioassay Sciences is targeted to serve the special needs of Bioassay Scientists globally. We work with the special needs of cell based potency assays, binding assays and animal assays to name a few. We have direct experience working with Vaccines, Antibodies, and other large molecule drug programs. Potency is one of the most important elements of a drug program as it directly links to clinical performance of the drug substance or drug product. We provide the method of calculation, validity criteria for relative potency, reportable results, outlier tests, equivalence testing and the associated assay validation and data management. Our SAS/JMP based platform for bioassays transcend the limitations of currently available off-the-shelf solutions.
Our clients directly benefit from putting their bioassays on our platform with reduced variation and a reduction in OOS and invalid rates.