Boehringer Ingelheim Austria named top CMO
Leadership award by Frost & Sullivan for its activities in the
contract manufacture of biotherapeutic proteins, and particularly
F&S said it gave the Austrian subsidiary of Germany's Boehringer Ingelheim the award for "successfully leveraging technological developments, while simultaneously providing superior upstream and downstream processing CMO services to customers across the globe."
In pioneering a CMO service for the fermentation and downstream purification of plasmid DNA (pDNA), said F&S, the company has established itself as the leading industry participant currently capable of producing pDNA on a large scale, and at current Good Manufacturing Practice (cGMP) compliant levels.
"As DNA-based gene therapy and gene vaccines move out of the research laboratory and into the clinic to treat a range of diseases, Boehringer Ingelheim Austria has spearheaded efforts to tap into the enormous market potential for the industrial production of pDNA," said F&S research analyst Phil Webster, adding that the company is poised to reap the benefit of the renewed interest in gene therapy now that initial safety issues are being resolved.
Webster said that the company is leading technology providers in the race to capitalise on the huge demand for new therapeutics by investing in an area which has received scant attention - technology innovation in downstream processing.
To cater to escalating demands for pharmaceutical grade pDNA, Boehringer Ingelheim Austria has designed an innovative production process that employs high cell density fermentation achieving high titres of up to 1g of pDNA per litre, followed by a powerful downstream process utilising convection interaction media (CIM) technology (developed in collaboration with BIA Separations of Slovenia) to produce pDNA of greater than 99 per cent purity.
"Customers will clearly benefit from the availability of pDNA in industrial production level quantities at low cost, high throughput and at over 99 per cent purity and suitability for therapeutic purposes," concluded Webster.