A novel technique for trehalose and sucrose determination in therapeutic monoclonal antibodies using a high-performance liquid chromatography-evaporative light scattering detector.

This study focuses on a novel technique for trehalose and sucrose determination in therapeutic monoclonal antibodies using a high-performance liquid chromatography-evaporative light scattering detector.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Sucrose and trehalose are commonly used excipients in therapeutic monoclonal antibodies that play a pivotal role in ensuring the safety and stability of drugs. Though it is necessary to control the concentrations of these substances during the quality control of their release, there is currently no comprehensive method for simultaneously... Research Background and Significance Therapeutic monoclonal antibodies (mAbs) represent a rapidly expanding class of biopharmaceutical drugs used to treat a variety of diseases, including cancers and autoimmune disorders. The formulation of these biologics often includes excipients such as trehalose and sucrose, which serve critical roles in stabilizing the protein structure, preventing aggregation, and ensuring long-term stability during storage. Accurate quantification of these sugars is essential in quality control to guarantee drug safety, efficacy, and batch-to-batch consistency. However, conventional analytical methods often struggle with simultaneous determination of trehalose and sucrose due to their structural similarity and the complex matrix of mAb formulations. This study by Yu et al. introduces a novel high-performance liquid chromatography (HPLC) method coupled with an evaporative light scattering detector (ELSD) that addresses these challenges, offering a sensitive and reliable approach for simultaneous sugar analysis in therapeutic mAbs. Experimental Design and Methodology The