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.
Immunoassay Testing during Drug Discovery, Preclinical, and Clinical Phases
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
ELISA based Immunogenicity Testing Assays
Enzyme-linked immunosorbent assay, commonly referred to as ELISA immunoassay, is unlike other immunogenicity or antibody-based assays. This is because the separation of non-specific and specific interactions in ELISA immunoassay occur through solid surface serial binding. The solid surface used is a polystyrene multiwell plate. The outcome of the experiment is assessed through the final colored product, which is correlated to the analyte amount found in the original sample matrix.
ELISA immunoassay provides a quick, simple, and robust method to handle several sample matrices in parallel. We offer the following ELISA immunoassay services, given their effectiveness in drug discovery and development.
Direct ELISA binds the antigen to the bottom of a 96-well plate. The primary antibody and an enzyme are conjugated, and the unbound antibodies are washed from the plate. After adding the chemical substrate, the enzyme causes a colorimetric reaction, which is then quantified.
Sandwich ELISA immunoassay binds two antibodies to the antigen to form a sandwich, antibody-antigen-antibody. When exposed to the substrate, the secondary antibody causes a colorimetric reaction. We use this method when the antigen concentration is low.
Competitive ELISA uses interference to measure the concentration of an antigen. In this ELISA immunoassay, we add the primary antibody to the sample antigen creating an antibody-antigen complex. This complex is added to a 96-well plate coated with another antigen. The primary antibody already bound to the sample antigen can’t attach to the plate antigen and gets washed off. Thus, if there is more sample antigen, the signal will be weaker because a smaller amount of antibody would have bound to the plate antigen.
Why Choose NorthEast BioLab for Your Immunoassay Drug Test?
At NorthEast BioLab, we follow EMA and FDA guidelines to understand the immunogenicity exhibited by protein therapeutics. Our scientists design each assay to follow FDA requirements, minimize interference, and have adequate sensitivity. Developing an immunoassay drug test using the above guidelines help us establish the therapeutic profile of the medication and collect predictive data for its immune response. Furthermore, this allows us to de-risk drug development and deliver a safer biotherapeutic.