生物制品中的残留宿主细胞蛋白及其检测方法

摘要

宿主细胞蛋白(host cell protein,HCP)是指生物制品中来自生产细胞系的宿主细胞的蛋白成分,主要包括宿主细胞分泌的蛋白以及细胞凋亡、代谢产生的部分结构蛋白.作为生物制品生产过程中的残留杂质,HCP具有潜在的安全风险,包括诱导免疫应答.建立合适的HCP残留量检测方法将有助于监测生产工艺,确保生物制品的质量和安全.此文主要对HCP的分类、质量控制标准、常见检测方法及其原理进行阐述.%Host cell proteins (HCPs) refer to protein components from host cells in biological products,including host cell-secreted proteins and structural proteins produced by apoptosis and metabolism of host cells.As the residual impurity during the production process of biological products,HCP has potential risks including induction of immune response.Developing suitable methods for HCP detection will help monitor the production process and ensure the quality and safety of biological products.This review summarizes classification and quality control standards of HCPs,as well as detection methods of HCPs and their mechanisms.