Roche Diagnostics - Germany

The fermentation facility is used for the GMP compliant production of a protein active ingredient, which is obtained by culturing genetically modified mammal cells.
The cells manufacture the desired protein and release it into the culture medium.

Temperature, pressure, stirrer speed, pH, and oxygen partial pressure are controlled in the bioreactors via measurement data from the ventilation system. These data are recorded and backed up with a computer system. Sterilizable membrane filters are used in the supply and exhaust ventilation systems of the reactors. The bioreactors were equipped with suitable receiver tanks for supplying the fermentation process with sterile bases, acids, antifoamers, and supplemental nutrients. Bioreactors, receiver tanks, and supply and drainage lines are sterilized with pure steam prior to use.