Current advances in separation chemistry for antibody purification and analysis.

This study focuses on current advances in separation chemistry for antibody purification and analysis.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Monoclonal antibodies (mAbs) have become essential in modern therapeutics, offering high specificity and efficacy in treating diseases such as cancer, autoimmune disorders, and infectious diseases. With the increasing demand for mAbs, robust analytical and purification technologies are critical to ensuring their safety, efficacy, and consistency. This review highlights recent advances... Research Background and Significance Monoclonal antibodies (mAbs) have revolutionized the therapeutic landscape, offering targeted treatment options for a diverse array of diseases including cancer, autoimmune disorders, and infectious diseases. Their specificity and efficacy have made them indispensable in biopharmaceutical development. However, the complexity of mAbs, characterized by large molecular size, heterogeneous glycosylation patterns, and potential presence of aggregates and variants, poses significant analytical challenges. Ensuring product safety, efficacy, and batch-to-batch consistency mandates robust purification and analytical techniques. High-performance liquid chromatography (HPLC) has emerged as a cornerstone technology in this context due to its high resolution, reproducibility, and adaptability. This study by Deol et al. (2025) addresses recent advances in HPLC-based separation chemistry that enhance antibody purification and analytical workflows, providing critical insights into method validation and practical applications relevant to the biopharmaceutical industry. Experimental Design and Methodology The study utilizes v