2013 AIChE Annual Meeting

Session: Application of Quality by Design in API Process Development

This session covers the application of Quality by Design (QbD) principles to the process development of pharmaceutical active ingredients (APIs) or drug substances (DS).

Chair

Jose E. Tabora, Bristol-Myers Squibb

Co-Chair

Fang Wang, Gilead Sciences

Presentations

03:15 PM

(343a) Improving the Robustness of a Pharmaceutical Crystallization Process
Alexander J. Marchut, Fredrik L. Nordstrom, Ketan Patel, Lakshmi Bhagavatula

03:40 PM

(343b) Development of An API Micronization Design Space Using a Design of Experiments Approach
Brian P. Chekal, Gregory S. Steeno

04:05 PM

(343c) Model Based Design of Experiments for Pharmaceutical Process Development
Jacob Albrecht, Jun Li

04:30 PM

(343d) Application of in-Situ Raman Spectroscopy in Monitoring the Dynamic Trends of Polymorphic Transformation and Hydrogenation Reaction
Haitao Zhang, Robert J. Prytko, Mike Sizensky, Kostas Saranteas

04:55 PM

(343e) Application of Combined Experimental and Modeling Approach to Understand pH Driven Reactive Crystallization
Shankar Vaidyaraman, Edward Conder, Gregory Brown, Angela Stack, Michael Phillips, Shekhar Viswanath, Eric Moher

05:20 PM

(343f) Model Based Development and Validation of a Preparative Size Exclusion Chromatography Step
Ernst B. Hansen, Thomas B Hansen, Lars Sejergaard