High above Lake Geneva at a location overlooking the spectacular panorama of the French Alps, one of the world’s most auspicious biotechnology facilities is taking shape. Starting in 2012, the cancer drug Erbitux will be produced at the Merck Serono Biotech Center in addition to the MS drug Rebif.
Merck Serono, Merck’s pharmaceutical arm, is investing €350 million in the biotechnology facility high above Lake Geneva, and in the process it will create 200 additional jobs for biologists, engineers, technicians and lab staff. Drugs made of complex molecules which cannot be chemically synthesized are produced using a biotechnology process on four lines which have a bioreactor capacity of 140,000 liters. The process includes creation of a cell bank, production of proteins in the bioreactors and filtration and purification to achieve ultra-pure protein concentrations.
The therapeutic proteins are produced by recombinant cell culture in a sterile, automatically controlled environment inside the bioreactors. Merck Serono uses both perfusion and fed-batch bioreactors. Using the perfusion technique, the medium is placed into the reactor and the product is harvested over a period of up to three months. With fed-batch reactors, the medium is placed into the bioreactor for a shorter period (3 weeks). All of the therapeutic product from a fed-batch reactor is harvested at the end of the process (i.e. harvesting only takes place once).
The proteins harvested from the bioreactor are then purified in a series of steps which are designed to isolate the target therapeutic protein. Chromatography and filtration are the two main techniques for purifying the proteins which are produced in the bioreactor. Purification is complete when the end product (the drug’s active ingredient) has reached maximum purity.
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