Analysis of Therapeutic Monoclonal Antibodies Using a Platform Size Exclusion-HPLC Method

Abstract

In biotherapeutics manufacturing, controlling size variants of therapeutic monoclonal antibodies (mAbs) is critical for ensuring product quality. Size-exclusion chromatography (SEC) is a leading method for analyzing size variants by separating high molecular weight and low molecular weight species from the monomer based on their hydrodynamic radius. We present a platform size exclusion-HPLC (SE–HPLC) method for analyzing a wide range of mAbs of different subclasses, demonstrating its feasibility through rigorous validation and evaluation. Our study highlights the method’s reproducibility, robustness, and ability to distinguish differences in size variants.