Anti-Drug Antibody (ADA) Assay Development & Validation

B2S provides the whole package for ADA testing. We employ the three-tiered approach to determining the immunogenicity potential of a biotherapeutic, as recommended by the regulatory authorities and best practices. We are at the forefront of providing sound statistical analysis for determination of the screening and confirmatory cut points, and our statistical reports to support the analysis are exceptional. We also support the characterization of the immune response with expertise in assays that determine neutralizing capabilities.

B2S Life Sciences