The use of capillary electrophoresis with entangled polymer matrix to analyse plasmid DNA and a cationic lipid/cholesterol liposome: DNA complex

A liposome based gene therapeutic product is being developed for the treatm ent of cystic fibrosis. The product comprises a complex of plasmid DNA and a cationic lipid/cholesterol liposome. Using CE with an entangled polymer m atrix, routine separations of linear, supercoiled and open-circle conformer s of DNA in plasmid DNA and the liposome complex have been performed. The C E method has been used to support novel quality control and process validat ion for the manufacture of plasmid DNA and to monitor the degradation of DN A in the liposome complex. Significant features of the method are simple sa mple preparation and the use of direct UV detection, avoiding the use of po tentially mutagenic reagents.