585 PAT for Process Understanding and Elucidation of Fundamental Phenomena in Drug Product/Substance Development

Wednesday, November 19, 2014: 3:15 PM
203 (Hilton Atlanta)
This session focuses on how PAT systems have been used to improve the process robustness and performance during drug substance and drug product development and its commercial implementation. The session welcomes presentations that describes successful as well as unsuccessful applications of PAT technologies. The session is also very interested in presentations in the application of PAT Data Management systems to obtain Process Understanding.

Pharmaceutical Discovery, Development and Manufacturing Forum
Pharmaceuticals (15B)

Brian R. Crump
Email: brian.r.crump@gsk.com

Pamela Bruen
Email: pamela.bruen@siemens.com

3:40 PM
(585b) On-Line Reaction Profiling in Pharmaceutical Process Development
Sarah Pulicare, Elie Chaaya, Paul Oram, Zhihao Lin, Ralph Calabria, Sherry Song, Jeonghan Park, Feng Xu and Azzeddine Lekhal

4:30 PM
(585d) PAT Implementation and QbD Control Strategy for Commercial Production of a Drug Substance
Elie Chaaya, Zhihao Lin, George Zhou, Sun Lei, Tseng-En Hu, Busolo Wabuyele and Cindy Starbuck

4:55 PM
(585e) Always the Same? Location of Segregation Via Spectroscopy
Roland Hohl, Otto Scheibelhofer, Patrick Wahl, Stephan Sacher and Johannes G. Khinast