Successful parallel development and integration of a plasmid-based biologic, container/closure system and electrokinetic delivery device.

We have developed three major technologies that allow plasmid-based products to be used for large-scale vaccination or therapeutic protein applications. Our team has integrated these components into one complete, cost-effective, easy-to-use system capable of rapid implementation under field conditions. The proprietary manufacturing process uses a lysis method and membrane-based chromatography to rapidly produce large-scale batches of plasmid. Plasmid doses are filled into the Becton-Dickinson Uniject container/closure system. The Uniject adapts to the electrode array of our constant current electrokinetic device, such that the plasmid is delivered in the area of tissue defined by the electrodes. Thus, plasmid uptake and expression levels are dramatically improved. This is the first completely integrated delivery system for plasmid-based products.