B2S Life Sciences® provides the whole package for Immunogenicity and ADA testing including advanced, custom report writing and analytical tools for late-stage immunogenicity studies. These tools include analytics, data management, data mining, reporting and web application development.
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 set an industry standard.
We also support the characterization of the immune response with expertise in assays that determine neutralizing capabilities.
Our team provides experienced support for immunogenicity testing in the following areas:
Reagent Generation and Life-Cycle Management
Anti-Drug Antibody (ADA) Assay Development & Validation
Immunoanalytics (Immunogenicity Analytics)
Preclinical / Clinical Immunogenicity Risk Assessment & Mitigation Planning
Preclinical Safety Testing / Immunotoxicology
Statistics and Estimation for Screening & Confirmatory Cut-Points
Development & Validation of Neutralizing Antibody Assays (NAB)