Dr.-Ing. Bernd-Markus Pfeiffer from Siemens and Dr. Patrick Sagmeister from Exputec presented in a joint talk at the BioInnovation Leader Summit in Berlin, Germany, how data from process development and process characterization studies is leveraged for cGMP manufacturing. Using InCyght from Exputec, users create integrated process models and soft-sensors.
Models can be implemented as soft-sensor function-blocks in Siemens DCS for manufacturing under cGMP and Part 11 compliance. The novel Bioreactor Control Toolbox is piloted at Novartis, Marburg. It features feedback control functions not only for physical parameters like O2 in fermenters, but also for physiological parameters such as growth-rate.