Identification of Surfactant Impact on a Monoclonal Antibody Characterization via HPLC-Separation Based and Biophysical Methods.

This study focuses on identification of surfactant impact on a monoclonal antibody characterization via hplc-separation based and biophysical methods.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the biopharmaceutical field. Surfactants, including polysorbates and poloxamers, play a crucial role in the formulation of therapeutic proteins by acting as solubilizing and stabilizing agents. They help prevent protein aggregation and adsorption, thereby enhancing the stability of drug substance and products., However, it is important to note that utilizing high concentrations of surfactants... Research Background and Significance Monoclonal antibodies (mAbs) are a cornerstone of modern biopharmaceutical therapeutics, offering targeted treatment options across various disease areas. Their structural complexity and sensitivity to environmental conditions pose significant analytical challenges, especially during formulation development. Surfactants such as polysorbates and poloxamers are widely incorporated into mAb formulations to enhance stability by preventing protein aggregation and surface adsorption. However, these surfactants themselves can interact with the protein or interfere with analytical measurements, complicating the characterization process. The study by Guo et al. (2024) addresses this critical issue by investigating the impact of surfactants on monoclonal antibody characterization using high-performance liquid chromatography (HPLC) coupled with biophysical methods. This work is significant because it provides a validated HPLC approach to reliably detect and monitor surfactant effects, thereby ensuring accurate biopharmaceutical analysis and supporting robust formulation development. Experimen