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Model Based Integrated Design of Pharmaceutical Drug Product and Process


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
Principal Scientist
Pfizer Global Research and Development
Process Modeling & Engineering Technology
445 Eastern Point Rd.
Groton, CT 06340
Phone Number: 860-715-0578
Fax Number: 860-686-6380
Email: Salvador.Garcia-Munoz@pfizer.com

Co-Chair:
Nick Sahinidis
John E. Swearingen Professor
Carnegie Mellon University
Chemical Engineering
5000 Forbes Avenue
Pittsburgh, PA 15213
Phone Number: 412-268-3338
Email: sahinidis@cmu.edu


Papers:
108a
Implementation of Novel Integrated Pharmaceutical Processes: A Model-Based Approach
Alicia Román Martínez, Technical University of Denmark; Rafiqul Gani, Technical University of Denmark; John M. Woodley, Technical University of Denmark
108b
Design Space of Pharmaceutical Processes Using Data-Driven Based Methods
Fani Boukouvala, Rutgers University; Fernando J. Muzzio, Rutgers University; Marianthi G. Ierapetritou, Rutgers University
108c
Model Based Control of Drug Substance Particle Size to Ensure Drug Product Uniformity
Jon Hilden, Eli Lilly and Company; Mark Schrad, Eli Lilly and Company; Jessica T. Sloan, Eli Lilly and Company; Jennifer Kuehne-Willmore, Eli Lilly and Company; Timothy Kramer, Eli Lilly and Company
108d
Modeling the Roll Compaction Process Using Finite Element Analysis
Ariel Muliadi, Purdue University; Carl R. Wassgren, Purdue University; James D. Litster, Purdue University
108e
Application of Model Based Drug Substance Particle Size Control in Drug Product Development
Mark Schrad, Eli Lilly and Company; Jon Hilden, Eli Lilly and Company; Jessica T. Sloan, Eli Lilly and Company; Jennifer Kuehne-Willmore, Eli Lilly and Company
108f
Investigation of a Tablet Coating Process Using a Multi-Model Simulation Approach
Daniele Suzzi, Research Center Pharmaceutical Engineering (RCPE); Gregor Toschkoff, Research Center Pharmaceutical Engineering (RCPE); Daniel Machold, Research Center Pharmaceutical Engineering (RCPE); Johannes Khinast, Graz University of Technology
See more of this Group/Topical: Topical i : Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
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