Adapting A High Cell Density Fed-Batch Process With Contract Manufacturing Organization (CMO)

By Claudia M. Huether, Christiane Schlottbom, and Ute Ehringer

In contract manufacturing one of the most challenging needs is the adaption of proprietary production processes, their optimization as well as process improvements after a transfer from one Contract Manufacturing; Organization (CMO) to another. Each single process modification has to be verified with comparable data. The following application note gives an example for such an adapting procedure achieved by the use of the DASGIP Parallel Bioreactor System. The established process of one CMO included a high cell density fed-batch process, controlled by the key process parameters pH, agitation, temperature and growth dependent glucose feeding. This process was adapted and optimized for the use with another CMO.