2008 Annual Meeting
(376a) Integration of PAT for the Development and Scale-up of a Hydrogenolysis Reaction
Authors
Jale Müslehiddinoglu - Presenter, Bristol-Myers Squibb Company
Paul Lobben, Bristol-Myers Squibb Company
Thomas Laporte, Bristol-Myers Squibb Company
Lori Spangler, Bristol-Myers Squibb Company
Daniel Fichana, Bristol-Myers Squibb Company
Shih-Ying Chang, Purdue University
Donald Kientzler, Bristol-Myers Squibb Company
Sushil Srivastava, Bristol-Myers Squibb Company
John Venit, Bristol-Myers Squibb Company
Robert Wethman, Bristol-Myers Squibb Company
San Kiang, 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.