(363a) Continuous Manufacturing Process Optimization and Scale-up: Three Step Reaction Telescope

A three-step telescoped continuous process has been designed and scaled up for the production of a drug substance intermediate. This work will describe the laboratory work completed to optimize the process and select equipment for commercial scale manufacturing. The selection of operating conditions was guided by Design of Experiments (DoEs) conducted in flow equipment at the laboratory scale using automated platforms and online analytical technologies. This data rich experimentation led to a quick determination of optimal reaction conditions and suitable operating ranges. Commercial equipment was chosen based on factors such as throughput, reactor geometry, and equipment capability. This telescoped process was successfully scaled up to commercial scale using modular equipment in a Good Manufacturing Practice (GMP) facility.