Standardization and Validation of Immunogenicity Assay Methods for Reliable Data
Immunogenicity analysis of a biotherapeutic involves evaluating its ability to trigger an immune response, whether through the production of antibodies in the humoral system or via cellular-based immune reactions. Anti-drug Antibody (ADA) assays, including screening, confirmation, titration, and neutralizing antibody (NAb) assay development, are commonly employed throughout the drug development process. These assays aim to […]
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