Plasmid DNA manufacturing technology - development of Boehringer Ingelheim with BIA Separations
Boehringer Ingelheim Austria GmbH and BIA Separations d.o.o. announced technological innovation in the field of plasmid DNA (pDNA) manufacture. In order to meet the growing need for pharmaceutical grade pDNA, Boehringer Ingelheim Austria has developed high cell density fermentation technology achieving titers of up to 1g pDNA per Liter, and has specifically designed equipment for automated and gentle lysis of biomass. A key and novel element of the production process is the use of Convection Interaction Media (CIM®) short monolithic columns for the purification of pDNA. The fast separation speed, outstanding capacity and excellent separation power of CIM® columns developed by BIA Separations allows to increase productivity 15-fold compared to traditional supports. "Our customers clearly benefit from this new development as the process is free of antibiotics, animal-derived raw materials, enzymes and organic solvents and employs powerful CIM® separation technology" says Dr. Kurt Konopitzky, Head of the Division Biopharmaceuticals/Operations at Boehringer Ingelheim Austria.
Boehringer Ingelheim Austria and BIA Separations are both committed to leadership of manufacturing technology and innovation of biopharmaceuticals. The process developed is capable of producing pDNA on a large scale and at current Good Manufacturing Practice compliant levels for clinical and commercial application.
After the successful completion of the joint development the two companies are collaborating on a non-exclusive basis where BIA Separations will supply Boehringer Ingelheim Austria with CIM® columns.
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