Immunogenicity Testing: Immune Responses Affecting Drug Safety & Efficacy
Immunogenicity testing plays a crucial role in measuring the immune response elicited by large molecule drugs during biotherapeutics R&D. Given its defense mechanism, the human immune system marks large molecules as foreign invaders and mounts a subsequent reaction. Typically, this happens through the production of antibodies to remove or destroy the external elements. During the immune response, the large molecules can create even larger macromolecules that further change the immunogenicity profile of the underlying drug. In other words, the immune response triggered by the therapeutic compound or its delivery vehicle can impact the efficacy and safety of the drug. Thus, immunogenicity testing is an essential step in biopharmaceutical development.
Immunogenicity assays are complicated because of multiple interactions that occur between the drug, target, and sample matrices. Thus, careful selection of the assay format is critical for further optimization and validation. NorthEast Biolab has extensive experience in designing, validating, and optimizing immunogenicity assays according to regulatory and safety guidelines by the FDA. Our scientists systematically develop your methods for high quality and reproducible immunogenicity assays. Usually, we support clients in developing a screening assay to measure immunogenicity. This is followed by titer and confirmation assays. We also help in developing custom immunogenicity assays by checking the risk or safety profile of the antibody and the intended purpose of the drug.
