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生物制品中宿主残留蛋白的风险分析和检测方法 被引量：4

Risk analysis and detection strategy of residual host cell protein in biological products
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摘要 新版《中华人民共和国药典》对生物制品的质量要求更高，其中对残留宿主细胞蛋白（HCP）在生物制品中含量的要求也越来越严格。目前HCP研究领域进展迅速。此文对生物制品中宿主残留蛋白的风险分析和检测方法作一综述。 Higher quality for the biological products is required in the latest edition of Pharmacopoeia of the People＇s Republic of China, and the control on the residual host cell protein （HCP） in biological products is more rigorous. Recently, the progress in the research of residual HCP is very rapid. This paper reviews risk analysis and detection strategy of residual HCP.
作者 杜洪桥(综述) 严家新(审校)
机构地区 武汉生物制品研究所有限责任公司基因工程室
出处 《国际生物制品学杂志》 CAS 2012年第2期82-86,共5页 International Journal of Biologicals
关键词 生物制品 宿主细胞蛋白 风险分析 系统生物学 Biological products Host cell protein Risk analysis Systems biology
分类号 R392-33 [医药卫生—免疫学]
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参考文献21

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二级参考文献12

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共引文献23

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引证文献4

二级引证文献7

国际生物制品学杂志
2012年 第2期

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