Plasmid DNA manufacturing technology.
Plasmid DNA manufacturing technology.
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DOI：
10.2174/187220807780809436
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发表时间：
2007-01-01
影响因子：
--
通讯作者：
Williams, James A
中科院分区：
文献类型：
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作者：
Carnes, Aaron E;Williams, James A
如今，随着下一代生物技术产品（基因药物和 DNA 疫苗）进入临床试验并最终进入制药市场，质粒 DNA 变得越来越重要。本综述在全面描述质粒制造知识产权情况的背景下，总结了与质粒制造相关的最新专利和专利申请。描述了质粒制造商开发或许可关键质粒制造技术的策略，其终点是有效生产公斤数量的质粒 DNA，其质量符合预期的欧洲和 FDA 商业质粒产品质量规范。
Today, plasmid DNA is becoming increasingly important as the next generation of biotechnology products (gene medicines and DNA vaccines) make their way into clinical trials, and eventually into the pharmaceutical marketplace. This review summarizes recent patents and patent applications relating to plasmid manufacturing, in the context of a comprehensive description of the plasmid manufacturing intellectual property landscape. Strategies for plasmid manufacturers to develop or in-license key plasmid manufacturing technologies are described with the endpoint of efficiently producing kg quantities of plasmid DNA of a quality that meets anticipated European and FDA quality specifications for commercial plasmid products.