Integration of PAT for the Development and Scale-up of a Hydrogenolysis Reaction

Although the Cbz deprotection reaction is a common organic reaction in the pharmaceutical industry, challenges were faced during the development and scale-up of this reaction at the API step due to the instability of the product in the reaction mixture. This led us to develop a control strategy as a part of quality by design approach. Consequently, a PAT (Process Analytical Technology) was used for continuous monitoring and control in order to ensure the quality of the product. This talk will describe the development of three in-process controls, using kinetics information from FTIR monitoring.