Neutralizing Antibody (NAb)
Immunogenicity research mainly focuses on the detection and characterization of anti-drug antibodies. Usually, data on the incidence, titer, duration, and neutralization ability of anti-drug antibodies (whether it is a neutralizing antibody) should be obtained. Samples that are confirmed to be positive by ADA will be further tested for neutralization activity to evaluate the ability/degree of anti-drug antibodies to neutralize the drug.
Methods for detecting anti-drug neutralizing antibodies include ligand binding methods and cell platform methods. The choice of methods for neutralizing antibodies should be based on the mechanism of action of the drug and its potential immunogenicity risks. If the drug’s mechanism of action is related to cell interaction, it is preferred to establish a cell platform method to detect neutralizing antibodies. The verification parameters of the neutralizing antibody detection method generally include threshold cut-off value determination, intra-assay, and inter-assay precision, sensitivity, selectivity, drug tolerance level, specificity, hook effect, robustness, and stability. As a professional macromolecular bioanalysis laboratory that meets GLP quality management regulations, Xining Bio has participated in the bioanalysis of a large number of NAb samples during clinical trials of macromolecular drugs.
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