Navigating the Frontier: Advances in monoclonal antibody purity control.

This review explores the evolving landscape of monoclonal antibody (mAb) purity assessment, highlighting the advancements in separation techniques aimed at improving resolution, speed, and precision of impurity detection, identification, and quantification.Traditional methods such as SDS-PAGE, isoelectric focusing electrophoresis and size-exclusion chromatography serve as a foundational tool, while advanced chromatographic techniques, including diverse modes of high-performance liquid chromatography (HPLC), and capillary electrophoresis (CE), offer improved capabilities for analyzing mAb structural integrity and impurities. These techniques separate different constituents in the samples based on their physicochemical properties such as size, charge, isoelectric point, hydrophobicity, and structure. The review discusses the principles and progressions of both traditional and advanced separation techniques and demonstrates their applications in large-scale mAb production and antibody-drug conjugate (ADC) analysis. Innovations in chromatography, such as superficially porous particles and novel stationary phases, address challenges like band broadening and protein adsorption.