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| 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 |
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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.
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Received: 17 September 2013
Published: 25 January 2014
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