Model Based Integrated Design of Pharmaceutical Drug Product and Process

Monday, November 8, 2010: 12:30 PM
Grand Ballroom B (Salt Palace Convention Center)

Description:
This session would specifically focus on work where a modeling approache coupled with optimization techniques are used in some decision making during the design of a pharmaceutical drug product and its process. This is an area of great interest from a Quality by Design perspective; and the use of modeling technology is an important trend in our business.


Sponsor:
Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsor(s):
Systems and Process Design (10A), Pharmaceuticals (15b)


Chair:
Salvador Garcia-Munoz
Email: Salvador.Garcia-Munoz@pfizer.com

Co-Chair:
Nick Sahinidis
Email: sahinidis@cmu.edu



12:30 PM


12:55 PM
(108b) Design Space of Pharmaceutical Processes Using Data-Driven Based Methods
Fani Boukouvala, Fernando J. Muzzio and Marianthi G. Ierapetritou


1:20 PM
(108c) Model Based Control of Drug Substance Particle Size to Ensure Drug Product Uniformity
Jon Hilden, Mark Schrad, Jessica T. Sloan, Jennifer Kuehne-Willmore and Timothy Kramer


1:45 PM
(108d) Modeling the Roll Compaction Process Using Finite Element Analysis
Ariel Muliadi, Carl R. Wassgren and James D. Litster


2:10 PM
(108e) Application of Model Based Drug Substance Particle Size Control in Drug Product Development
Mark Schrad, Jon Hilden, Jessica T. Sloan and Jennifer Kuehne-Willmore


2:35 PM
(108f) Investigation of a Tablet Coating Process Using a Multi-Model Simulation Approach
Daniele Suzzi, Gregor Toschkoff, Daniel Machold and Johannes Khinast