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. The initial stages following the identification of a target molecule are laboratory-based.
Chemists focus on route scouting (e.g., investigating the best synthetic approach) and defining the process design space (e.g., establishing process conditions that ensure consistent, desirable results). Later stages focus on the scale-up of a high-quality product and aim to produce larger quantities of the molecule for additional purposes (e.g., clinical studies or chemical testing).
Activities involved in chemical process development and scale-up focus on process understanding and control with the goal of supporting quality by design (QbD) objectives. Process variables that affect critical quality attributes and product yield are well-defined, measured, and understood. A design of experiment (DoE) approach and process analytical technology (PAT) is often used to aid in accomplishing these goals. DoE helps to screen and identify optimal values within the reaction space while PAT provides a means to continuously monitoring across the entirety of the chemical development process.
Scale-up efforts encompass a range of activities involved in the transition from lab to plant including investigating potential process hazards, understanding reaction kinetics and thermodynamics, identifying and characterizing impurities, mixing and mass transfer studies, heat transfer, and removal studies as well as crystallization and polymorph control.