PAT for Process Understanding, Reduced Testing, and Elucidation of Fundamental Phenomena in Drug Product/Substance Development

Real time analysis with PAT systems has been widely applied in the pharmaceutical industry in recent years. This session focuses on a few of the many successful examples showing how and why PAT systems enhances process understanding, robustness and performance for both drug substance and drug product. Innovative rather than traditional applications of PAT demonstrating the value of qualitative or quantitative method development for better drug process monitoring and control will be featured. For instance, how chemometrics, or data management can be leveraged for optimized utilization of real time process information.