| 重组抗体药物的质量控制 |
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| 引用本文： | 高凯,陶磊,王军志. 重组抗体药物的质量控制[J]. 中国新药杂志, 2011, 0(19) |
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| 作者姓名： | 高凯 陶磊 王军志 |
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| 作者单位： | 中国食品药品检定研究院重组技术产品室; |
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| 基金项目： | 国家“重大新药创制”科技重大专项(2009ZX09307-001); 国家高技术研究发展计划(863计划)(2007AA021601,2007AA021204) |
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| 摘 要： | 重组抗体药物是生物工程关键技术的前沿成果,在肿瘤、自身免疫、器官移植和感染性疾病的治疗中均取得了显著疗效,在生物技术药物市场中的比重也在迅速攀升。作为生物技术产业化领域最成功的产品之一,如何通过质量控制确保抗体药物的安全有效一直是本领域的关注热点。文中就重组抗体药物质量控制的关键环节、进展及未来需要进一步开展的工作作一简要综述。
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| 关 键 词： | 生物技术药物 重组抗体 质量控制 |
Quality control for recombinant therapeutic antibodies |
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| GAO Kai,TAO Lei,WANG Jun-zhi. Quality control for recombinant therapeutic antibodies[J]. Chinese Journal of New Drugs, 2011, 0(19) |
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| Authors: | GAO Kai TAO Lei WANG Jun-zhi |
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| Affiliation: | GAO Kai,TAO Lei,WANG Jun-zhi(Division of Biopharmaceuticals,National Institutes for Food and Drug Control,Beijing 100050,China) |
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| Abstract: | Recombinant therapeutic antibodies are one of the great achievements of modern biotechnology.There is no doubt that the uses of recombinant therapeutic antibodies were successful in treating various life-threatening and chronic diseases,including cancer,autoimmunity,transplantation and infectious diseases.Its share in the global biopharmaceutical market also increased rapidly in recent years.Meanwhile,as one of the most successful outcome biotherapeutics,how to ensure the safety and efficacy of recombinant ... |
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| Keywords: | biopharmaceutics recombinant therapeutic antibodies quality control |
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