| 细胞培养工艺条件对抗体异质性影响的研究进展 |
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| 引用本文： | 段须杰,刘睿,徐卫涛,任彤,罗厚勇. 细胞培养工艺条件对抗体异质性影响的研究进展[J]. 生物工程学报, 2013, 29(12): 1880-1886 |
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| 作者姓名： | 段须杰 刘睿 徐卫涛 任彤 罗厚勇 |
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| 作者单位： | 江苏先声药业有限公司，江苏 南京 210042;江苏先声药业有限公司，江苏 南京 210042;江苏先声药业有限公司，江苏 南京 210042;江苏先声药业有限公司，江苏 南京 210042;江苏先声药业有限公司，江苏 南京 210042 |
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| 基金项目： | “重大新药创制”科技重大专项 (No. 2012ZX09105301) 资助。 |
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| 摘 要： | 抗体药物具有靶向明确、副作用小等优势，近年来受到国内外药企的广泛关注。然而，动物细胞大规模培养和抗体质量分析已然成为我国的抗体药物产业化的主要限制因素，尤其是细胞培养工艺条件对抗体异质性的影响非常显著，如何有效通过优化工艺条件来满足抗体药物开发要求成为迫在眉睫的问题。文中简要综述了近年来细胞培养工艺条件对抗体异质性影响的技术进展，并对未来国内抗体药物开发作了展望。
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| 关 键 词： | 抗体，细胞培养，异质性，质量，工艺条件 |
| 收稿时间： | 2013-05-08 |
Effect of cell culture conditions on antibody heterogeneity |
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| Xujie Duan,Rui Liu,Weitao Xu,Tong Ren and Houyong Luo. Effect of cell culture conditions on antibody heterogeneity[J]. Chinese journal of biotechnology, 2013, 29(12): 1880-1886 |
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| Authors: | Xujie Duan Rui Liu Weitao Xu Tong Ren Houyong Luo |
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| Affiliation: | Jiangsu Simcere Pharmaceutical Group, Nanjing 210042, Jiangsu, China;Jiangsu Simcere Pharmaceutical Group, Nanjing 210042, Jiangsu, China;Jiangsu Simcere Pharmaceutical Group, Nanjing 210042, Jiangsu, China;Jiangsu Simcere Pharmaceutical Group, Nanjing 210042, Jiangsu, China;Jiangsu Simcere Pharmaceutical Group, Nanjing 210042, Jiangsu, China |
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| Abstract: | With the advantage of clear target and little side effect, antibody drug has attracted widely attention of worldwide pharmaceutical companies. However, large scale mammalian cell culture and antibody quality analysis are the bottlenecks of antibody drug industrialization in China. Especially due to the significant effect of cell culture conditions on antibody heterogeneity. Therefore, it is extremely urgent to optimize cell culture conditions to favor the demands of antibody drug development. This review summarized the most recent advances in the effect of cell culture conditions on antibody quality, followed by addressing the key issues that might be strategically important for domestic antibody drug development. |
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| Keywords: | antibody cell culture heterogeneity quality process condition |
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