系统生物学在生物制品宿主细胞蛋白检测中的应用

摘要

New edition of Chinese Pharmacopoeia makes the higher quality requirements for the biologic products, and the limitation on residual host cell protein (HCP) in biologic products is also more rigorous. Emerging systems biology, including proteomics, genomics and bioinformatics, is now widely applied in the study of HCP. This paper reviews the application of the systems biology for identification and evaluation of HCP in biologic products.%新版<中国药典>对生物制品的质量要求更高,其中对生物制品宿主细胞蛋白(host cell protein,HCP)残留量的限制也更严格.新兴的系统生物学(包括蛋白质组学、基因组学和生物信息学)已在HCP的研究中获得了广泛应用.此文综述系统生物学在生物制品HCP鉴定和评估中的应用.