Sample Analysis of a Multidomain Fusion Protein Drug with Linker Peptides: Tiered Domain Characterization of Neutralizing and Anti-Drug Antibodies in Correlation to Pharmacokinetic Profiles

AAPS PharmSci 360 2025 -- The purpose of this study was to evaluate anti-drug antibody (ADA) and neutralizing antibody (NAb) responses in patient serum samples following treatment. The ADA/NAb presencewas detected, drug domains targeted by these antibodies were characterized, and their impact on PK profiles and therapeutic efficacy was assessed.