Comprehensive Characterisation of Monoclonal Antibodies Using Charge Variant Analysis Coupled to High-Resolution Mass Spectrometry

摘要

Native mass spectrometry (MS) is an increasingly important technique for the characterisation of recombinant protein-based biopharmaceutical products such as monoclonal antibodies (mAbs), offering several benefits over MS workflows that involve protein denaturation steps. However, coupling native MS with established protein separation methods like cation exchange chromatography for charge variant analysis (CVA) has traditionally proven to be challenging. This article highlights how modern high-resolution mass analysers with extended mass capabilities are supporting the confident characterisation of biopharmaceutical products and details a global CVA-MS method for the multiparameter analysis of complex protein therapeutics.