The Puresyn Plasmid purification process uses our proprietary resin, PolyFlo®, to purify supercoiled plasmid from crude lysate prepared using standard alkaline lysis methods in the absence of RNAse treatment or detergent extraction. PolyFlo is a chemically inert non-porous polymer. The PolyFlo purification process uses principles of ion-paired reverse-phase chromatography for separation of nucleic acid species based on the combination of differences in hydrophobicity and charge density. The addition of the ion-pairing agent TBAP to a crude lysate creates the ion-pair bridge between the phosphate backbone of DNA and the hydrophobic PolyFlo matrix. The strength of the binding is based on the number of phosphates (size) and charge density. This permits simultaneous separation of RNA, chromosomal DNA from plasmid as well as non-supercoiled isoforms, such as open circular plasmid from supercoiled plasmid. The inherent hydrophobic nature of the resin allows for removal of contaminating endotoxins during the process as well.
A Drug Master File for PolyFlo is on file with the US FDA.