Evaluation of a cIEF Fractionation Workflow for Offline MS Analysis of Charge Variants of the Monoclonal Antibody Matuzumab.

ABSTRACT: Biological drugs like monoclonal antibodies require careful analysis and characterization to ensure product quality, safety, and efficacy. Charge variants of the molecule are of key interest and are analyzed using imaged capillary isoelectric focusing (icIEF). However, deeper characterization of these variants poses challenges. Two workflows for their characterization exist: an ion-exchange chromatography method for variant collection before mass spectrometry (MS) analysis, which is labor-intensive, and direct coupling of CE to MS, which allows detailed structural characterization but has limitations, for example, due to incompatibilities with ES ionization using high BGE concentrations. This study evaluates a platform that fractionates charge variants for offline MS analysis. The suitabil

SUBMITTER: Wittmann A 

PROVIDER: S-EPMC11865688 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature