Boehringer has made use of purification columns developed by BIA Separations to develop a high cell density fermentation technology that can achieve production titres of up to 1g pDNA per litre.
In the proicess, BIA's Convection Interaction Media (CIM) short monolithic columns have been combined with specifically designed equipment for the automated and gentle lysis of the biomass. The result is a system that allows fast separation speed, high capacity, and excellent separation power, giving a 15-fold increase in productivity compared to traditional supports, claims Boehringer.
The new process is free of antibiotics, animal-derived raw materials, enzymes and organic solvents, according to Dr Kurt Konopitzky, head of the biopharmaceuticals/operations division at Boehringer.
The industry is increasingly demanding 'cleaner' production approaches that minimise the use of materials that can affect the performance of the finished product and could be a source of harmful contaminants. This not only makes for a safer product, but also reduces costs as downstream processing demands can be reduced.
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.
CIM monolithic supports are chromatographic and bioconversion supports that are based on a highly cross-linked porous monolithic polymer, with even pore-size distribution that improves the reliability and reproducibility of separation. BIA is the only manufacturer of these columns, which are used both in the research and production environments in the pharmaceutical sector, and can be used for a wide variety of laboratory steps, such as separation and purification of peptides, proteins, oligonucleotides and polynucleotides; fast-in process control during production and downstream processing; solid phase extraction and sample enrichment; quality control and fast method development.
Boehringer is one of the leaders in plasmid DNA production, and earlier this year its Austrian subsidiary won a Frost and Sullivan award for pioneering a contract manufacturing service for the fermentation and downstream purification of this type of compound.