Chemical process development is focused on the development, scale-up and optimization of a chemical synthetic route, leading to a safe, reproducible and economical chemical manufacturing process. Following the identification of a target molecule by chemists, the initial stages of chemical process development are laboratory based and focus on route scouting, i.e., investigating the best synthetic approach, and in later stages, to produce larger investigative quantities of the molecule for additional studies (e.g., pre-clinical and clinical studies in the pharmaceutical industry). After the synthesis route is chosen, the focus shifts to scaling up the synthesis including defining the process design space, i.e., defining a set of variables and parameters that result in a process that ensures a reliable, quality product.
Chemical process development activities focus on process understanding and control to supporting Quality by Design objectives. Process variables that affect critical quality attributes of the product are defined, measured and monitored as are those that optimize product yield. A Design of Experiment approach is often utilized to aid in accomplishing these goals. Furthermore, Process Analytical Technology is employed to measure and monitor those parameters that define key quality attributes as well as for supporting process optimization studies. Scale-up efforts involve investigation into potential process hazards, understanding reaction kinetics and thermodynamics, identifying and characterizing impurities, mixing and mass transfer studies, heat transfer and heat removal studies as well as crystallization and polymorph control.