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Immunogenicity Monitoring

Meaning

Immunogenicity Monitoring is the systematic surveillance and analysis of an individual’s immune response against an administered therapeutic peptide or protein product. This crucial clinical practice involves testing for the presence, concentration, and neutralizing capacity of anti-drug antibodies, or ADAs, that the patient’s immune system may generate against the treatment. It is a mandatory part of the clinical development and post-marketing surveillance for all peptide-based and biologic therapies to ensure patient safety and long-term treatment efficacy.