2011 Annual Meeting

Session: Scale-up of Pharmaceutical Manufacturing Processes: Toward a QbD Approach

Chair

Huiquan Wu, FDA

Presentations

03:15 PM

(754a) Application of a Joint Risk Assessment Platform to Identify Suitable Drug Substance and Drug Product Process Options

Jonathan Brown, Olav Lyngberg, Lindsay Hobson, San Kiang

03:35 PM

(754b) Improved Process Understanding Through Implementation of QbD Methodologies

Shane T. Grosser, Aaron Moment, Angela Spartalis, George Zhou, Paul Fernandez

03:55 PM

(754c) Harnessing Computational Fluid Dynamics (CFD) to Guide Reliable Scale-up of Pharmaceutical Processes

Ann M. Czyzewski, Hsien-Hsin Tung, Shailendra V. Bordawekar

04:15 PM

(754d) Model-Guided Quality by Design: A Case Study On a Pharmaceutical Final Intermediate

Zhongmin Xu, James S. Bergum, Thomas L. Laporte, Jose E. Tabora, Lori A. Spangler

04:45 PM

(754e) Incorporating Computational Fluid Dynamics Methods for Quality by Design Framework for Exploring Design Space of a Fermentor

Sravan Nallamothu, R. Muralikrishnan

05:05 PM

(754f) Scaling up Strategy for Continuous Powder Mixing Process

Yijie Gao, Fernando J. Muzzio

05:25 PM

(754g) Modified Application of Johanson's Model towards Roller Compaction