Immunogenicity

Why test for immunogenicity?

The immunogenicity of biological drugs can usually induce the body to produce immune responses to them and produce anti-drug antibodies.The CAR structure on the surface of CAR-T cells is not a receptor normally expressed on the surface of human T cells, and it is possible for the body to generate anti-drug antibodies to CAR-T cells during use. Therefore, the immunogenicity of CAR-T cell drugs needs to be evaluated during drug development and treatment.

Anti-drug antibodies generally fall into two categories: neutralizing and nonneutralizing. Non-neutralizing antibodies bind to the inactive sites of CAR-T cells and do not directly affect drug activity. The neutralizing antibody directly binds to the active site of CAR-T cells and prevents or reduces the binding of CAR-T cells to tumor surface targets, exerting a great influence on drug efficacy.

What are Anti-idiotype antibodies?