(336c) (Invited Plenary Talk) Optical Sensing and Cell Culture

Real-time monitoring of pH, cell density, and dissolved oxygen concentration with optical sensors is challenging traditional biological cell culture assumptions. By providing insights into cellular metabolism and localized environmental conditions, optical sensing of critical process parameters has already proved useful for the analysis, experimental design, and manufacturing control in a variety of fields, simultaneously improving results, increasing reproducibility, and decreasing cost. Minimally invasive and non-invasive sensing modalities are changing long-held cell culture paradigms and results are being visualized in real-time. FDA’s Process Analytical Technology (PAT) initiative outlined in a guidance document issued in 2004 encourages manufacturers to use the latest scientific advances in pharmaceutical manufacturing and technology and implement continuous real time quality assurance. The use of PAT tools such as process analyzers that measure critical quality attributes and process control tools is encouraged and ideally these tools should be introduced during the development phase. Monitoring, understanding, and regulating critical cell culture parameters has the potential to make scale-up easier, faster, and less costly, easing the path from laboratory research to realized industrial application and decreasing time from bench to bedside.