Navigating the Frontier: Advances in monoclonal antibody purity control.

This study focuses on navigating the frontier: advances in monoclonal antibody purity control.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. 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,... Research Background and Significance Monoclonal antibodies (mAbs) have emerged as pivotal biopharmaceutical agents due to their specificity and efficacy in treating a wide array of diseases, including cancers and autoimmune disorders. However, ensuring the purity of mAb products is critical for both safety and therapeutic effectiveness. Impurities such as aggregates, charge variants, and degradation products can impact efficacy and immunogenicity. Traditional analytical methods like SDS-PAGE, isoelectric focusing electrophoresis, and size-exclusion chromatography (SEC) have long been utilized to assess mAb purity. Yet, these techniques often lack the resolution, speed, or quantitative accuracy required for modern biopharmaceutical development. The study by Song et al. (2025) addresses these challenges by advancing high-performance liquid chromatography (HPLC) methodologies tailored for improved purity control of mAbs. This work is significant as it reflects the evolving frontier in biopharmaceutical analytics, emphasizing precision, robustness, and practical applicability in quality control workflows.