关于我国药典单克隆抗体类生物治疗药物总论的思考

doi:10.13523/j.cb.20140117

中国生物工程杂志

2014, Vol. 34

Issue (1): 127-134 DOI: 10.13523/j.cb.20140117

医药生物技术专栏

关于我国药典单克隆抗体类生物治疗药物总论的思考

高凯¹, 徐志凯², 任跃明³, 王兰¹, 王军志¹, 郭中平³

1. 中国食品药品检定研究院;
2. 中国人民解放军第四军医大学;
3. 国家药典委员会

Points to Consider for the General Monograph of Monoclonal Antibody Based Biotherapeutics in Chinese Pharamacopeia

GAO Kai¹, XU Zhi-kai², REN Yue-ming³, WAN Lan¹, WANG Jun-zhi¹, GUO Zhong-ping³

1. Chinese National Institute for Food and Drug Control;
2. The Fourth Military Medical University;
3. Chinese Pharmacopoeia Commission

全文: PDF(479 KB) HTML

摘要： 单克隆抗体类生物治疗药物目前是国内外生物药中增长最快的领域。药品的规范生产与质量控制与其安全有效性息息相关，欧美药典中均设有对此类药品质量控制的总体要求，2015版《中国药典》在进一步保障药品安全和提高质量控制水平的编制指导思想下，也拟纳入对单克隆抗体类生物治疗药物的总体要求，就相关起草工作从产品涉及范畴、制造与产品检定等方面进行阐述。

关键词： 单克隆抗体; 抗体类生物治疗药物; 药典标准

Abstract: Monoclonal antibody based biotherapeutics reflect the rapid progress achieved in global biopharmaceuticals area. Good manufacture practice and quality control are key contributions to the safety and efficacy of these drugs. General requirements for the control of monoclonal antibodies are embodied in European and United States Pharmacopeia. Chinese Pharmacopeia intend to draft and include general monograph of monoclonal antibody based biotherapeutics in the coming new edition, under the directions to further improve drug safety as well as to upgrade the technology level of quality control. This paper is to pave the way for the drafting of monograph of monoclonal antibody based biotherapeutics from the aspects including scope, manufacture and release control etc.

Key words: Monoclonal antibody Monoclonal antibody based biotherapeutics Pharmacopeia specification

收稿日期: 2013-09-17 出版日期: 2014-01-25

ZTFLH:

R917

基金资助: 国家科技重大专项资助项目（2014ZX09304311、2012ZX09304010）

通讯作者: 郭中平，E-mail：guozhongping@chp.org.cn E-mail: guozhongping@chp.org.cn

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引用本文:

高凯, 徐志凯, 任跃明, 王兰, 王军志, 郭中平. 关于我国药典单克隆抗体类生物治疗药物总论的思考[J]. 中国生物工程杂志, 2014, 34(1): 127-134.

GAO Kai, XU Zhi-kai, REN Yue-ming, WAN Lan, WANG Jun-zhi, GUO Zhong-ping. Points to Consider for the General Monograph of Monoclonal Antibody Based Biotherapeutics in Chinese Pharamacopeia. China Biotechnology, 2014, 34(1): 127-134.

链接本文:

https://manu60.magtech.com.cn/biotech/CN/10.13523/j.cb.20140117 或 https://manu60.magtech.com.cn/biotech/CN/Y2014/V34/I1/127

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