Bioassay and Potency Testing

Development of bioassays for batch release testing are a vital part of biologic drug product development. They are required to ensure the quality control of proteins, monoclonal antibodies (mAbs) or biosimilars. Once established, these assays are used to perform release testing to determine the purity, concentration, identity, safety and ensure consistency of the final drug or chemical product.

We can work with you on both the early assay development and validation to then convert those established assays to perform batch release testing under GMP.