Immunogenicity of a drug refers to the ability of the drug and/or its metabolites to induce an immune response to itself or related proteins or immune-related events. The impact of immune response is huge, from the temporary emergence of non-clinically significant anti-drug antibodies to serious life-threatening. 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).
Anti-drug antibodies (ADA) are antibodies that specifically bind to drugs or drug-related substances, which can affect the efficacy, pharmacokinetics, and safety of drugs. Therefore, the detection and characterization of ADA are critical in the development and evaluation of biopharmaceutical products.
The detection of ADA should usually adopt a multi-level analysis method.
First, all samples should be screened and tested, and then the specificity of the suspected antibody-positive sample should be confirmed. A titer test is then performed on a sample that is determined to be positive for the antibody.
Different methods and instruments can be used for anti-drug antibody detection, including but not limited to: direct method, bridging method, and homogeneous combination method.
Neutralizing Antibody (NAb) are a subclass of ADA that specifically bind to and inhibit the biological activity of the drug. The presence of NAbs may result in decreased drug efficacy and/or increased risk of adverse events. Therefore, the detection and characterization of NAbs are critical in the development and evaluation of biopharamceutical products.
Different methods and instruments can be used for NAb detection and characterization, including but not limited to:
The validation of immunogenicity assays is a critical step in ensuring the accuracy, precision, and reliability of the results. Validation parameters for ADA and NAb detection methods generally include:
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