Plasmid DNA takes steps forward

Boehringer Ingelheim and BIA Separations, have announced a technological innovation in the field of plasmid DNA (pDNA) manufacture.

To meet the growing need for pharmaceutical grade pDNA, Boehringer has developed a high cell density fermentation technology achieving titers up to 1g pDNA per litre, and has specifically designed equipment for the automated and gentle lysis of the biomass.

A key and novel element of the production process is the use of Convection Interaction Media (CIM) short monolithic columns, developed by BIA Separations, for the purification of pDNA. The fast separation speed, outstanding capacity, and excellent separation power of CIM columns, allows a 15-fold increase in productivity 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 the powerful CIM separation technology,' said Dr. Kurt Konopitzky, head of the biopharmaceuticals/operations division, Boehringer Ingelheim.

The process produces pDNA on a large scale and follows GMP for clinical and commercial applications.

Boehringer and BIA, the only worldwide manufacturer of short monolithic columns optimized to meet the research and production needs of the biotechnology industry, are committed to developing manufacturing technology that leads to innovative biopharmaceuticals. After successfully co-developing this novel process, the two companies are collaborating on a non-exclusive basis where BIA will supply Boehringer with CIM columns.