Immunogenicity Testing Assay: Assessing Undesired Immune Responses Affecting Drug Safety & Efficacy
Immunogenicity testing assay plays a crucial role in measuring the immune response elicited by large molecule drugs during biotherapeutics R&D. Given the 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.
ELISA based Immunogenicity Testing Assay: Direct ELISA, Sandwich ELISA, or Competitive ELISA Assay
Immunogenicity testing is critical in measuring the therapeutic antibody concentration in the body. These tests also measure soluble protein biomarkers and anti-drug antibodies. The findings from these measurements impact dose selection and the safety profile of the drug. The soluble protein biomarkers quantified during immunoassay drug test can reveal target engagement, provide a mechanism of action, and predict the immune response related to the drug.
Samples for immunogenicity testing contain complex matrices that can create considerable interference and cause inaccuracies. Hence, scientists formulate strategies to reduce interference in the immunoassay test and accurately support the development of therapeutic antibodies and other drug candidates in the human body.
NorthEast Biolab has 15+ years of experience in designing, optimizing, and validating assays for biotech and pharma companies. We implement GLP and GCP evaluation of a new biologics in preclinical and clinical stages, respectively. Our veteran scientists have worked on a variety of immunogenicity testing assay to provide highly sensitive and selective methods.
Our services include the following procedures, at all stages of the immunogenicity assay development process:
- Purification, modification, and procurement of antibodies
- Immunogen and antigen preparation
- Cell line formation
- Development and optimization of immunoassays
- Reagent preparation
- Anti-drug antibody screening
- Titration and isotyping