Moving From Batch to Continuous Flow Chemistry Production with PAT

Multiple benefits can be realized by converting batch into continuous processes. To facilitate such transition, science-based approaches to process development and manufacturing (viz., Quality by Design principles) must be adopted. NIR spectroscopy (NIRS) is a true enabler of such approaches where process monitoring is intertwined with process understanding, state estimation and control goals. In this study, NIRS has proven to be a valuable tool for fast, cost-efficient development and optimization of a continuous flow system by opening a window into reaction chemistry and kinetics, as well as a better understanding and control of the underlying variability sources. The implementation of a NIR-based in-process control (IPC) method will enhance process state estimation and overcome the limited info obtained by discrete sampling and time consuming reference analytics, thus ensuring by design high yields and product quality.