Current Status of Anti-Drug Antibody Analysis Using Immunocapture-Liquid Chromatography/Mass Spectrometry

Abstract

During drug development, anti-drug antibodies (ADA) is closely monitored for immunogenicity assessment. Ligand binding assay is currently the most widely used platform for ADA detection. Very recently, immunocapture-LC/MS was developed for ADA analysis including isotyping and semi-quantitation. This mini-review summarizes literatures pertaining to immunocapture-LC/MS ADA analysis with focus on methodology, applications and regulatory aspects. Current thinking and considerations as well as outlook are also presented.