The figures are impressive: the plant comprises 120,000 L of bioreactor capacity, 65 km of new piping, 10,000 m² of additional production and cleanroom facilities, 2700 m² of logistics and support space, storage capacity for 4500 pallets and a treatment plant for the biological treatment of 1200 m³ of wastewater.

The Center produces large amounts of active ingredients for biopharmaceuticals, such as Merck’s cancer drug Erbitux^®, a wide range of biosimilars and Rebif^® (interferon beta-1a) and a second messenger used in multiple sclerosis treatment. Produced in animal cells and subsequently released into the surrounding culture medium, they are then harvested and purified.

Because only a tiny amount is administered to each patient, production volumes are very small. "It only takes a couple of kilograms of Rebif^® to supply the entire world market,” said a spokesperson from the Merck Serono Biotech Center: “By contrast, therapeutic antibodies for targeted cancer therapies such as Erbitux^® are produced by the ton or hundreds of kilograms, as dosages can be as much as 18,000 times higher than for Rebif^®.”

At the Merck Serono Biotech Center, process development and production are neatly dovetailed. Process development begins in the Cell Sciences Department, where the gene with the blueprint for producing the biopharmaceutical is introduced into the animal cells. The next task is to select cell lines that produce the therapeutic protein in high yields and outstanding quality. These cell lines are then transferred to Process Development, which determines the optimal conditions for cultivation, purification and the eventual development of a fully commercial production process.

To expedite throughput, robots are used to simultaneously test as many parameters in parallel as possible using a minimal number of cells. Similarly, plant engineering software and automation ensure that all of the production processes are closely monitored and controlled.