Application of Ion Exchange Chromatography for Pharmaceutical Plasmid Analysis

作者：Zhang Minlian^*; Hu Ding; Liu Mengru; Kong Xian

来源：Progress in Chemistry, 2010, 22(2-3): 482-488.

• gene therapy
• DNA vaccine
• plasmid
• ion exchange chromatography

Gene therapy and DNA vaccines have shown a great potential for the cure and diagnosis of major diseases. The monitoring of the downstream procedure, as well as the assessment of final product purity and specifications, is a key issue in process validation and final product approval. In this review, the application of anion exchange chromatography to pharmaceutical plasmid analysis was reviewed. There are four types of chromatography media for plasmid analysis, including porous, perfusion, pellicular and non porous media. The separation and analysis properties of the four types of chromatography media on plasmid with impurities and supercoiled plasmid with other isoformers are summarized and compared with each other. The main problems and future prospects are discussed from the viewpoint of practical application.

• 出版日期2010-3
• 单位清华大学