文献类型：期刊文献

中文题名：治疗性DNA疫苗生产工艺及质量检测的研究

英文题名：Studies on Production Process and Quality Inspection of Therapeutic DNA Vaccine

作者：王浪[1];陆兵[1];夏杰[1];徐殿胜[1]

机构：[1]华东理工大学生物反应器工程国家重点实验室,上海200237

年份：2009

卷号：26

期号：2

起止页码：49

中文期刊名：化学与生物工程

外文期刊名：Chemistry & Bioengineering

收录：CSTPCD

语种：中文

中文关键词：DNA疫苗;生产工艺;纯化;层析;质量检测

外文关键词：DNA vaccine; production process ; purification; chromatography ; quality inspection

摘要：研究了治疗性DNA疫苗的大规模生产工艺。利用硫酸铵沉淀法和超滤技术对发酵菌体的碱裂解液进行预处理,除去发酵液中大量的RNA;然后依次用凝胶过滤层析、亲和层析和离子交换层析对DNA疫苗进行纯化;并对最终质粒DNA溶液进行全面的质量检测。结果表明,DNA疫苗总产率可达62%,各项质量指标均符合药用DNA疫苗质量标准。该纯化工艺操作简便、成本低,适用于大规模工业化生产。
A process for production of therapeutic DNA vaccine was investigated. The major steps included the removal of RNA from clarified Escherichia coli cell lysate by ammonium sulfate precipitation arid ultrafiltration, and then purification of DNA vaccine by gel filtration chromatography, affinity chromatography and ionic exchange chromatography in turn. Quality inspection was performed on the final purified plasmids. It showed that the total yield of DNA vaccine was 62 %, all the quality inspection indexes of the final purified DNA vaccine met the requirements of medical use. The developed purification process was simple and low-cost. It could be applied to the large-scale industrial production.