Friday, November 21, 2008: 10:45 AM-1:15 PM
Room 113-B (Pennsylvania Convention Center)

Pharmaceuticals (15b)

#769 - PAT Applications in Pharmaceuticals (15B01)
This session will discuss novel approaches using PAT to monitor, model, and/or control a chemical or biological processes. Papers discussing PAT applications at the pilot plant or manufacturing scale will also be considered. The PAT initiative encourages industry to introduce on-line, in-line, or at-line analytical tools to identify key process parameters that affect product quality through the use of scientifically based process design and statistical tools (“Guidance for Industry PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance,” September 2004)
Chair:Adeyma Arroyo
CoChair:Sze Wing (Candice) Wong
10:45 AMIn Process Wireless Coating Bed Temperature Monitoring: Application of a Novel Commercial off the Shelf Solution for PAT and Qbd Applications
Zane Arp, Christine McDade
11:05 AMRapid Characterization of Virus Solutions for Filter Challenge Studies
Leonard F. Pease III, De-Hao Tsai, Kurt A. Brorson, Kenneth D. Cole, Michael Zachariah, Michael J. Tarlov
11:25 AMAnomaly Detection and Diagnosis In Continuous Pharmaceutical Manufacturing: An Ontological Approach
Intan Munirah Hamdan, Gintaras V. Reklaitis, Venkat Venkatasubramanian
11:45 AMMonitoring and Control of Cell Culture Bioreactors Using on-Line Scanning Dielectric Spectroscopy
Cary Opel, Ashraf Amanullah
12:05 PMLasentec Fbrm Ipc-PAT Method Development and Validation for Wet Milling Process
Mario Hubert, Chiajen Lai, Gregory Lane, Thomas LaPorte, Paul Lobben, Lori Spangler
12:25 PMProcess Analytical Technology Based Robust Scale-up of Pharmaceutical Crystallization Processes
Zoltan K. Nagy, Levente L. Simon, Konrad Hungerbuehler
12:45 PMOptimization of API Drying Via Hemi-Solvate Conversion Kinetics
Kimberley C. Allen, Nandkishor K. Nere, James C. Marek

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