343 Application of Quality by Design in API Process Development

Tuesday, November 5, 2013: 3:15 PM
Golden Gate 2 (Hilton)
Description:
This session covers the application of Quality by Design (QbD) principles to the process development of pharmaceutical active ingredients (APIs) or drug substances (DS).

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pilot Plants (12b)

Chair:
Jose E. Tabora
Email: jose.tabora@bms.com

Co-Chair:
Fang Wang
Email: fang.wang@gilead.com

- indicates paper has an Extended Abstract file available on CD.


3:15 PM
(343a) Improving the Robustness of a Pharmaceutical Crystallization Process
Alexander J. Marchut, Fredrik L. Nordstrom, Ketan Patel and Lakshmi Bhagavatula

3:40 PM
(343b) Development of An API Micronization Design Space Using a Design of Experiments Approach
Brian P. Chekal and Gregory S. Steeno

4:05 PM
(343c) Model Based Design of Experiments for Pharmaceutical Process Development
Jacob Albrecht and Jun Li
File available
4:30 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 and Kostas Saranteas

4:55 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 and Eric Moher
File available
5:20 PM
(343f) Model Based Development and Validation of a Preparative Size Exclusion Chromatography Step
Ernst B. Hansen, Thomas B Hansen and Lars Sejergaard
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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