Immunogenicity Assays for Antibody–Drug Conjugates: Case Study with Ado-Trastuzumab Emtansine

Abstract

The tiered immunogenicity assay strategy for T-DM1 allowed detection of antitherapeutic antibodies to all components of the ADC in multiple nonclinical and clinical studies. Characterization strategies implemented in clinical studies provided additional insights into the specificity of the immune response.