Available for licensing from NIH is a method for large scale production, recovery, and purification process for plasmid DNA manufacturing meeting human clinical trial requirements.  DNA plasmid recovery and purification methods can separate plasmid from contamination from a variety of sources including cellular debris and proteins as well as genomic DNA and RNA.  Traditionally, DNA plasmid recovery methods utilizing column chromatography have had poor results such as product elutes with broad smears rather than sharp peaks, product elutes appearing in the flow through thereby preventing isolation from lysate components, and monomeric supercoiled plasmids are not separated from other forms of plasmids.  To overcome these shortcomings, a fermentation, recovery, purification, and formulation process for the production of plasmid has been developed.  The overall recovery of this process is greater than 400 mg of formulated final product per kilogram (wet weight) of E. coli cell paste.

Applications: 

·   Produce clinical grade plasmid DNA for clinical trials

·   Therapeutic reagents

Market: 

This technology has potential uses in drug manufacturing and clinical studies.  In the United States alone, there were approximately over 40,000 clinical trials conducted.  The potential market is worth several billion dollars.

Related Publications: 

1.     N Horn et al. U.S. Patent No. 5,707,812, Purification of plasmid DNA during column chromatography.

2.     R Lemmens et al. Supercoiled plasmid DNA: selective purification by thiophilic/aromatic adsorption. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Feb 5;784(2):291-300.  [PubMed abs]

3.     J Urthaler et al. Application of monoliths for plasmid DNA purification development and transfer to production. J Chromatogr A 2005 Feb 11;1065(1):93-106.  [PubMed abs]

HHS Reference No. E-033-2007/0 – Research Tool

Inventors: 

Yueqing Xie et al. (NCI/SAIC)

Licensees Sought:

This technology is available as a non-exclusive license.

Collaborative Research Opportunity: 

The National Cancer Institute - Frederick is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize A Production, Recovery and Purification Process for Plasmid DNA Clinical Manufacturing.  Please contact John Hewes, Ph.D. at 301-496-0477 or hewesj@mail.nih.gov for more information.