Immunogenicity refers to the ability to elicit an immune response that the antigen can stimulate specific immune cells, activate, proliferate, differentiate, and ultimately produce antibodies to immune effector antibodies and sensitized lymphocytes. In recent years, biopharmaceuticals have developed rapidly, but their immunogenicity is not an unsolved problem. Therefore, it is important to assess the immunogenicity of biopharmaceuticals to ensure their drug safety. Creative Biolabs can provide a comprehensive assessment of immunogenicity, a variety of evaluation methods and technical services to help you keep your medication safe.
The direct binding assay is one of the easiest evaluation methods in competitive binding assays, generally, by using a kit to verified, for example, enzyme-linked immunosorbent assay (ELISA) has been widely used for the quantitative determination of IgG. In the past few years, the enzyme-labeled antibody technology for antigen localization has been developed into trace substances in liquid samples. The evaluation method often has advantages such as easy-to-use and automated, high throughput, high therapeutic tolerance, low-cost generic reagents, as well as instrument.
➢ to bind the antigen or antibody to the surface of a solid phase carrier and maintain its immunological activity.
➢ linking an antigen or an antibody to an enzyme to form an enzyme-labeled antigen or antibody, and retains both its immunological activity and the activity of the enzyme.
➢ At the time of the assay, the test specimen (the antibody or antigen to be assayed therein) and the enzyme-labeled antigen or antibody are reacted in different steps with the antigen or antibody on the surface of the solid phase carrier.
➢ The antigen-antibody complex formed on the solid phase carrier is separated from other substances by washing, and finally, the amount of the enzyme bound to the solid phase carrier is proportional to the amount of the test substance in the sample.
➢ After the substrate of the enzyme reaction is added, the substrate is catalyzed by the enzyme to become a colored product, and the amount of the product is directly related to the amount of the substance to be tested in the sample, so that it can be qualitatively or quantitatively analyzed according to the depth of the color reaction.
➢ Due to the high catalytic frequency of the enzyme, the reaction effect can be greatly amplified, so that the measurement method achieves high sensitivity.
Fig.1 Assay formats among direct binging assay, competitive binding assay, and substrate degradation assay. (Geschwindner, 2012)
It is very necessary to evaluate the immunogenicity of biopharmaceuticals in the early stages of administration. Creative Biolabs provides a rich research background about direct binding assay and immunogenic diagnosis. If you want to know more information, please contact us in time and we are happy to provide you with detailed information and standard technical services.
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