Immunogenicity Testing

Immunogenicity refers to the ability of an antigen to induce an immune response. Proteins, peptides, monoclonal antibodies (mAbs), PEGylated proteins, multi-domain biotherapeutics, antibody-drug conjugates (ADCs), and cellular therapeutics are likely to be antigenic, which greatly affects the design of safety evaluation programs for biotechnology products. Charles River has the expertise and resources to develop and validate methods as well as perform sample analysis to help you fully study the immunogenicity of your novel compounds in discovery, preclinical, and clinical stages. This also includes evaluation of the immune response in preclinical models and clinical samples from vaccine studies.

    • Anti-drug (ADA) or antigen/antibody screening
    • Confirmatory
    • Titration and isotyping
    • Neutralizing antibody (nAb)
    • ELISA
    • Electrochemiluminescence (ECL) and Meso Scale Discovery (MSD)
    • Flow cytometry
    • SPEAD (solid-phase extraction with acid dissociation)