Scientists at The Austrian Centre of Industrial Biotechnology (acib) and the University of Natural Resources Vienna (BOKU) have come up with a continuous purification method for valuable drugs that could cut production costs.
The researchers have developed a method that has the potential to reduce the production costs of highly valued drugs significantly. Two-thirds of therapeutic antibodies are currently produced using Chinese hamster ovary cells (CHO). The major cost factor for industry is purification using ‘protein A’ affinity chromatography where tens of thousands of litres of culture volume have to be processed annually. Such purification can account for about 80% of production costs.
Researchers from acib and BOKU have developed a new downstream processing method for recombinant antibodies from clarified CHO cultures. The purification method combines a calcium-phosphate flocculation with a subsequent cold ethanol precipitation in a tubular reactor realised as a double-pipe heat exchanger that is operated in counter-current flow.
A feasibility study exemplified by the purification of immune globulin G (IgG) shows that the continuous method can compete with protein A affinity chromatography in terms of yield, and outperforms chromatography on speed.
A further advantage is that the operation parameters can be easily transferred from the used batch to the continuous approach. In combination with a prior concentration step, the new method is suitable for purification of low titre supernatants.
‘Our method shows great potential as a new platform technology for the pharmaceutical industry,’ said Professor Alois Jungbauer, who is in negotiations with several international companies over building pilot plants.
Acib has extensive experience in CHO technologies and recently sequenced the genome of the Chinese hamster. The purification method was published in the Biotechnology Journal and can be found at http://goo.gl/KYvWLD.