2008 Annual Meeting

(376a) Integration of PAT for the Development and Scale-up of a Hydrogenolysis Reaction

Authors

Müslehiddinoglu, J. - Presenter, Bristol-Myers Squibb Company
Lobben, P., Bristol-Myers Squibb Company
Laporte, T., Bristol-Myers Squibb Company
Spangler, L., Bristol-Myers Squibb Company
Fichana, D., Bristol-Myers Squibb Company
Chang, S. Y., Purdue University
Kientzler, D., Bristol-Myers Squibb Company
Srivastava, S., Bristol-Myers Squibb Company
Venit, J., Bristol-Myers Squibb Company
Wethman, R., Bristol-Myers Squibb Company
Kiang, S., Bristol-Myers Squibb Co
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.