【蛋白质组学在生物制药高风险宿主细胞蛋白鉴定与控制中的应用】
Host cell proteins (HCPs) are bioprocess impurities originating from the host cells used in biopharmaceutical manufacturing. Identifying and controlling high-risk HCPs is essential for maintaining product quality and shelf life. Notably, HCPs with hydrolase activity can degrade formulation excipient polysorbates, reducing drug stability. In this presentation, we will discuss advanced LC-MS-based proteomic approaches, including high-throughput proteomics and activity-based protein profiling (ABPP), to identify high-risk HCPs for biopharmaceutical process development and to enable product quality control.