Degradation and in-use stability study of five marketed therapeutic monoclonal antibodies by generic weak cation exchange liquid chromatographic method ((WCX)HPLC/DAD).

This study focuses on degradation and in-use stability study of five marketed therapeutic monoclonal antibodies by generic weak cation exchange liquid chromatographic method ((wcx)hplc/dad).. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Therapeutic monoclonal antibodies (mAbs) represent a very important class of the current biopharmaceutics. The great complexity of their structure made necessary the use of different analytical approaches for assessing different physico-chemical properties. In this work, weak cation exchange (WCX) high performance liquid chromatography with diode array detection ((WCX)HPLC/DAD) is used... Research Background and Significance Monoclonal antibodies (mAbs) have emerged as pivotal therapeutics in the treatment of a wide array of diseases, including cancer, autoimmune disorders, and infectious diseases. Due to their complex molecular architecture—comprising multiple domains, glycosylation sites, and charge variants—mAbs require robust analytical methodologies to ensure their safety, efficacy, and quality throughout their shelf life and clinical use. Degradation and in-use stability studies are essential to understand how these biologics behave under storage conditions and during administration. Weak cation exchange high-performance liquid chromatography ((WCX)HPLC) coupled with diode array detection (DAD) offers a powerful, generic approach to separate charge variants, which are critical quality attributes influencing therapeutic performance. This study by Martínez-Ortega et al. provides a comprehensive evaluation of five marketed therapeutic mAbs using a generic WCX-HPLC/DAD method, addressing a significant need for standardized, reliable analyt