S27: A platform for IS-free pDNA production: Use of Clean Genome® E. coli for elimination of IS contaminated pDNA therapeutics. 

Tuesday, November 8, 2011: 3:30 PM
Islands Ballroom G-J (Marriott Marco Island)
Steve Palmieri, Mike Panechelli, Dogan Ornek, Maureen Hamilton and Mark Lewandowski, Lonza Biologics, Inc., Hopkinton, MA
When plasmids are isolated from E. coli they are typically contaminated with mobile DNA elements called insertion sequences (IS elements).  Drug quality, safety and efficacy may be negatively impacted by the presence of IS elements in plasmids.  In order to eliminate the IS concern altogether, Lonza has integrated Scarab host technology into its pDNA production platform.  Recent improvements to the fermentation and primary recovery steps were made for improved manufacturability.  This platform enables the production of IS-free plasmid DNA biotherapeutics.