The methods used to make blockbuster monoclonal antibodies like Herceptin and Avastin are not sufficient to produce next generation biopharmaceuticals according to Wolfgang Kuhne, Roche’s VP of technical development bioprocessing.
He told delegates at the Bioprocess International European Summit in Vienna, Austria that making candidates like ACE910 – a bispecific antibody granted breakthrough designation for haemophilia last September – had required a considerable process development effort.
“There are no more classical standard approaches and we have to make a huge effort for our bioprocessing development,” he said.
Downstream challenges
The initial stages of making bispecific antibodies are very similar to those used to make ‘simpler’ drugs like Herceptin.
The molecules are produced in bioreactors by cultured Chinese Hamster Ovary (CHO) cells.
The challenge, Kuhne continued, had been the development of purification processes capable of harvesting the innovative molecules.
Established technologies like Protein-A based resins had not proved effective he said, adding that processes like virus removal are also more complex for bispecific antibodies than for mAbs.