Immunogenicity

Immunogenicity describes the ability of a therapeutic product to trigger an immune response in a patient, resulting in the formation of anti-drug antibodies or other immune-mediated reactions that may affect safety, efficacy, or pharmacokinetics. This phenomenon can occur with biologics including monoclonal antibodies, recombinant proteins, gene therapies, and cell therapies. Immunogenicity outcomes range from clinically insignificant antibody formation to severe effects including hypersensitivity reactions or loss of treatment response.

The biopharmaceutical industry evaluates immunogenicity as a critical safety and performance consideration throughout development. Preclinical risk assessment examines factors including sequence non-humanity, aggregation propensity, glycosylation patterns, formulation components, and manufacturing impurities. Clinical studies measure anti-drug antibodies, neutralising antibodies, and associated clinical impact. Risk mitigation approaches include protein engineering to increase human similarity, glycoengineering to avoid immunogenic glycans, improved purification processes, and formulation optimisation minimising aggregation. Regulatory submissions require immunogenicity assessment plans, validated assays, and interpretation of clinical relevance.