(284a) Mass Transfer Characterization of a Biphasic Continuous Reaction System for Improved Process Understanding and Control

Continuous processing, while commonplace in other chemical industries, remains a novel and emerging technology in the pharmaceutical industry and presents potential advantages in manufacturing footprint, quality, and enhanced control of mass and heat transfer limitations associated with scale-up. Recent developments in the regulatory environment  and pressure to control costs have encouraged growth of continuous manufacture in the pharmaceutical industry. Despite numerous advantages, continuous processing contains challenges in areas such as understanding laboratory and pilot plant equipment capabilities for improved process control. One fundamental element to process development is the characterization of continuous equipment to enable process understanding in terms of engineering first principles. With process understanding, effective control strategies can be implemented to deliver quality product at the lowest possible cost.

A key asset in the continuous portfolio at GlaxoSmithKline involves process development of a partially miscible chemical reaction mixture, in which the reaction is limited by mass transfer. To support process understanding, control, and scale-up from the laboratory to pilot plant facilities, a protocol was developed to characterize the mass transfer of the system in terms of fundamental engineering first principles. This presentation will detail the characterization of a partially miscible mass transfer limited reaction for continuous processing including observations of equipment specific scale-up parameters.