Online glucose-lactate monitoring and control in cell culture and microbial fermentation bioprocesses

Introduction Conventional biopharmaceutical manufacturing is characterized by validated process steps and extensive lab testing procedures. The FDA PAT-Guidance recommends the use of potential for improving development, manufacturing, and quality assurance through innovation in product and process development, process analysis and process control. Measurement of glucose, as a major nutrient during cell cultivation and microbial fermentation, has a key role for controlling the status of the cultivation process. Together with the amount of lactate and additional process parameters, like pH and DO, it gives the possibility to calculate specific consumption rates of nutrients. The user gets information about the status of the culture and of the cells.