This preliminary program is subject to change.

Integrated Model Based Design of Pharmaceutical Product and Process


Description:
The application of Process Systems Engineering tools to the design of a pharmaceutical product implies the consideration of all the interactions across materials and processes onto the performance of the final drug product. This session invites contribution where a model-based approach is taken to simultaneously design processing trains while accounting for incoming materials and target product characteristics.

Sponsor:
Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsor(s):
Computing Systems and Technology Division (10), Process Development Division (12)


Chair:
Salvador García-Muñoz
Senior Principal Scientist
Pfizer Worldwide R&D
Process Modeling and Engineering Technology
445 Eastern Point Road
Groton, CT 06340
Phone Number: 1 860 715 0578
Fax Number: 860-686-6380
Email: Salvador.Garcia-Munoz@pfizer.com

Co-Chair:
Christopher L. Burcham
Engineering Research Advisor
Eli Lilly and Company
Chemical Product Research and Development; Particle Design Laboratory
Lilly Research Laboratories
Indianapolis, IN 46285
Email: cburcham@lilly.com


Papers:
A Model-Based Approach for the Construction of Design Spaces in Quality-by-Design
Masako Kishida, University of Illinois at Urbana-Champaign; Richard D. Braatz, Massachusetts Institute of Technology
Fluid Bed in a Flash
Stephan Sacher, Research Center Pharmaceutical Engineering; Otto Scheibelhofer, Research Center Pharmaceutical Engineering; Roland Hohl, Research Center Pharmaceutical Engineering; Sharareh Salar-Behzadi, Research Center Pharmaceutical Engineering; Detlev Haack, Hermes Arzneimittel GmbH; Kai Koch, Innojet Herbert Hüttlin; Jose C. Menezes, Research Center Pharmaceutical Engineering GmbH; Johannes G. Khinast, Graz University of Technology
From Experimental Data to Building Integrated Dynamic Flowsheet Models for Pharmaceutical Processes
Fani Boukouvala, Rutgers University; Fernando J. Muzzio, Rutgers, The State University of New Jersey; Marianthi Ierapetritou, Rutgers, The State University of New Jersey
Modeling and Simulation of a Wurster Column for Particulate Coating Using Population Balance Moldels and Thermodynamics
Jianfeng Li, Purdue University; Salvador García-Muñoz, Pfizer Worldwide Research & Development; William R. Ketterhagen, Pfizer Inc.; James D. Litster, Purdue University
Exceptional Event Managemnt Applied to Continuous Pharmaceutical Manufacturing
Anshu Gupta, Purdue University; Gintaras V. Reklaitis, Purdue University; Venkat Venkatasubramanian, Purdue University
Modelling of a Filter Drying Process
Giovanni Giorgio, GlaxoSmithKline Ltd.; Jason Mustakis, Pfizer Inc.; Mark A. Pinto, Process Systems Enterprise; Sean K. Bermingham, Process Systems Enterprise