| 大规模生产制备质粒DNA技术进展 |
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| 引用本文： | 刘佳,张庆林.大规模生产制备质粒DNA技术进展[J].生物技术通讯,2004,15(4):409-410,413. |
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| 作者姓名： | 刘佳 张庆林 |
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| 作者单位： | 军事医学科学院,放射医学研究所,北京,100850 |
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| 摘 要： | 质粒DNA疫苗或基因治疗剂是生物制品的新品种。鉴于质粒DNA表达效率低、持续时间短，需建立一套大规模生产制备质粒DNA的工艺，即发酵、碱性裂解、分离纯化及质量控制。目前质粒DNA大规模生产已经达到千克级水平，一些产品正在进行临床实验。
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| 关 键 词： | 质粒DNA 质量控制 生物制品 疫苗 基因治疗剂 品种 |
| 文章编号： | 1009-0002(2004)04-0409-03 |
Process on scaleable for the manufacture of plasmid DNA |
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| DNA LIU Jia,ZHANG Qing-lin Institute of Radiation Medicine,Academy of Military Medical Sciences,Beijing,China.Process on scaleable for the manufacture of plasmid DNA[J].Letters in Biotechnology,2004,15(4):409-410,413. |
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| Authors: | DNA LIU Jia ZHANG Qing-lin Institute of Radiation Medicine Academy of Military Medical Sciences Beijing China |
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| Institution: | DNA LIU Jia,ZHANG Qing-lin Institute of Radiation Medicine,Academy of Military Medical Sciences,Beijing100850,China |
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| Abstract: | Plasmid DNA is a new bioproduct.It is necessary to design scaleable processes for the manufacture of thera-peutic quantities of plasmid DNA,due to its low transfection efficiency and short duration.The process includes fermenta-tion,recovery and clarification,purification and quality-control.Now these processes routes can be scaled-up to produce kilogram quantities to meet clinical needs. |
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| Keywords: | plasmid DNA scaleable processes quality-control |
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