The immunogenicity of a drug refers to the ability of a drug and/or its metabolites to induce an immune response or immune-related events against itself or related proteins. The impact of the immune response is huge, ranging from the temporary appearance of anti-drug antibodies with no clinical significance to severe life-threatening events.
For most drugs, adverse immune reactions are generally caused by immune responses mediated by humoral immune mechanisms. Therefore, immunogenicity research mainly focuses on the detection and characterization of anti-drug antibodies (ADA). ADA testing should usually adopt a multi-level analysis method. First, perform screening tests on all samples, then perform confirmation tests on the specificity of suspected antibody-positive samples, and perform titer tests on samples that have been determined to be antibody-positive.
Different methods and instruments can be used for the detection of anti-drug antibodies, including but not limited to the direct method, bridging method, and homogeneous combination method. The bridge method based on the MSD platform is very classic in ADA detection; the validation parameters of ADA testing methods generally include threshold cutoff value determination, intra-assay, and inter-assay precision, sensitivity, selectivity, drug tolerance level, specificity, hook effect, robustness, and stability.
Ipilimumab (CTLA-4), Conbercept, ranibizumab, ramucirumab, Atezolimab (PD-L1), Pertuzumab, Cetuximab Erbitux (Cetuximab), CD40 antibody, SOST antibody, IgE antibody, MCF antibody, PCSK9 antibody, IL-6 antibody, IL-17A antibody, IL-23 antibody, etc.
- EqCAM/CD3, CD3/Her2, PDL1/TGF-β, PDL1/VEGF, (nanobody 1), EGFR/IL-10,CTLA-4/PD1, Her2/Her2