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

Successful parallel development and integration of a plasmid-based biologic, container/closure system and electrokinetic delivery device
Available online 24 August 2005.
Henry Hebela, , Heather Attraa, , Amir Khana, and Ruxandra Draghia-Akli, a
Vaccine
Volume 24, Issue 21 , 22 May 2006
ScienceDirect
Copyright ? 2005 Elsevier Ltd All rights reserved.
aADViSYS Inc., 2700 Research Forest Drive, Suite 180, The Woodlands, TX 77381, USA
Abstract
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.
Keywords: Plasmid; Manufacturing; Vaccine; Electroporation; Uniject?

Corresponding author. Tel.: +1 281 296 7300; fax: +1 281 296 7333.
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