Immunogenicity Overview

The clinical consequences of antibody formation vary with the type and quantity of antibody present, and it may effect drug PK, PD, efficacy, and safety. Preclinical immunogenicity is not predictive of clinical immunogenicity in humans, but it helps to understand the findings in a toxicological venue. Assays for ADA detection are grouped into two categories: binding assays and neutralizing antibody assays, which result in different clinical implications.

Immunogenicity is presented in two perspectives: Product oriented attributes include structural variation, biologics formulation, manufacturing process and binding assay utilized. Patient oriented attributes include dose, route, dosing frequency, time length of administration, and idiosyncrasy. Preclinical and clinical assessments of immunogenicity are requited for biologics development.