Thursday, November 20, 2008: 8:30 AM-11:00 AM
307-A (Pennsylvania Convention Center)

Pharmaceuticals (15b)

#607 - Modeling in the Pharmaceutical Industry I (15B04)
The development of pharmaceuticals involves the development of both process and chemistry/formulation to produce the active pharmaceutical ingredient/final drug product. We invite contributions from industry and academia that address system-level process simulation (cycle time analysis, mass and energy balances, equipment usage, scheduling etc.) and/or more detailed unit operations modeling during process development and scale-up in pharmaceutical synthesis and formulation (e.g. reaction steps, kinetics, solvent chasing, crystallization, filtration, drying). Particular consideration will be given to examples of model development from laboratory data with model validation during scale-up and clear savings or greater process understanding as a result of process modeling.
Chair:Richard Schild
CoChair:Christopher L. Burcham
8:30 AMOverview of Models Used in Design Space Determination: A Regulatory Perspective
Sharmista Chatterjee
8:50 AMReaction Kinetics for An API Process with Multiple Pathways and Hidden Intermediates
David Willcox, Deepak Ahuja, Tim Towne, Wenke Li, Todd McDermott
9:10 AMAn Application of Reaction Engineering and Modeling In Quality by Design
Daniel Hallow, Justin Burt, Boguslaw Mudryk, Lucius Rossano, Srinivas Tummala
9:30 AMOntology-Based Modeling Environment for Pharmaceutical Product Development: Milling Case Study
Pavan Kumar Akkisetty, Pradeep Suresh, Gintaras V. Reklaitis, Venkat Venkatasubramanian
9:50 AMBreak
10:00 AMMapping the Droplet Drying Phenomena within a Fluidized Bed Coater as a Prediction Tool for Coating Qualities
Fesia L. Laksmana, Paul J.A. Hartman Kok, Herman Vromans, Henderik W. Frijlink, Kees Van der Voort Maarschalk
10:20 AMUse of Mathematical Models to Scale up Lyophilization Process
Venkat R. Koganti, Sumit Luthra, Evgenyi Shalaev, Larry Gatlin
10:40 AMMagnetically Enhanced Centrifugation for Continuous Biopharmaceutical Processing
Fei Chen, Kenneth A. Smith, T. Alan Hatton

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