Rentschler Biotechnologie reports that it has commissioned two new GMP manufacturing suites. Both systems will be used to produce therapeutic proteins and mAbs.
The new fermenter lines with 500-L working volume each are sized such that depending on the respective requirements, different cell culture processes can be run, according to the company. The ensuing protein purification is performed in two suites upstream and two suites downstream of the obligatory virus inactivation.
Rentschler also plans to add two new 2,500-L multiprocess fermentation suites in mid-2008. Both can optionally be used to run perfusion processes. The expansion project as a whole—the two 500-L and two 2,500-L systems—comprises a new laboratory building, a central energy station, a logistics space as well as additional facilities for sterile filling of syringes and injection vials.