Process Monitoring with Disposable Chemical Sensors Fit in the Framework of Process Analysis Technology (PAT) for Innovative Pharmaceutical Development and Quality Assurance

摘要

The innovative principle of enzymatic sensors applied to monitor the feeding process in disposable bioreactors is described. Innovative is the type of enzyme immobilized within the 'paste' to monitor L-glutamate. Innovative is the application of the miniaturized disposable sensor developed at C-CIT AG for continuous monitoring. The sensor allows the amount of the digested nutrient to be estimated from the amperometric signal. Innovative is the wireless signal transduction between the sensor mounted to the bioreactor and the signal receiver. An example of a process control run is given and, also, the biocompatibility and the specifications of the biosensors. The comparison of results evaluated by different analytical methods is discussed.