Immunogenicity refers to the ability of a substance, particularly a therapeutic protein or biologic, to trigger an immune response in the body. This immune response can lead to the formation of anti-drug antibodies (ADAs), which may neutralize the drug’s efficacy, alter its pharmacokinetics, or in rare cases cause serious safety reactions such as hypersensitivity or autoimmune diseases. Therefore, the assessment of immunogenicity is a critical aspect of safety and efficacy evaluation for all biological medicinal products.
For CROs, the investigation of immunogenicity requires a multi-tiered testing strategy. Initially, screening assays are used to detect the presence of ADAs. Positive samples are then confirmed in a confirmatory assay and further characterized to determine whether they are neutralizing antibodies (NAbs). The development and validation of these highly specialized bioanalytical assays is complex and requires considerable expertise. The results of the immunogenicity assessment are an essential component of the regulatory dossier and critical for the benefit-risk evaluation of the biologic.