626 Mechanistic Models for Integrated Pharmaceutical Product and Process Design


Description:
These sessions illustrate the advantages of integrating fundamental design concepts into process development to support pharmaceutical manufacturing. Drug substance and drug product applications are both considered for this session track. Contributions that incorporate process modeling with experimental designs to optimize product performance in drug substance and/or drug product are encouraged for submission. Modeling approaches including CFD, DEM, FEM, PBM, Monte Carlo and other methods, or a focus on thermodynamic, kinetic and transport parameter estimation, are welcomed.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pharmaceuticals (15B)


Chair:
Salvador García-Muñoz
Senior Principal Scientist
D
Process Modeling and Engineering Technology
445 Eastern Point Road
Groton, CT
06340
Email: sal.garcia@lilly.com

Co-Chair:
Dimitrios I. Gerogiorgis
Lecturer
University of Edinburgh
Institute for Materials & Processes (IMP), School of Engineering
The King's Buildings
Edinburgh
EH9 3JL
Fax Number: +44131 650 6551
Email: D.Gerogiorgis@ed.ac.uk


Papers:
626a
Liposome Processing Using a Turbulent Jet in Co-Flow: Experiments and Multi-Scale Models
Antonio Costa, UConn; Raj Mukherjee, UConn; Anand Gupta, UConn; Gowtham Yenduri, UConn; Xiaoming Xu, Office of Testing and Research, U.S. Food and Drug Administration; Celia N. Cruz, U.S. Food and Drug Administration; Bodhisattwa Chaudhuri, University of Connecticut; Diane Burgess, UConn
626b
Optimal Design of Separation Systems for Continuous Manufacturing of Nevirapine, an Active Pharmaceutical Ingredient (API) for H.I.V. Treatment
Samir Diab, University of Edinburgh; Dimitrios I. Gerogiorgis, University of Edinburgh
626c
Utilizing Mechanistic Modelling to Assist in the Process Development of Pharmaceutical Drug Substance Processes
Rosario Porrazzo, Glaxo Smith Kline; Sam Wilkinson, Process Systems Enterprise; Niall Mitchell, Process Systems Enterprise
626d
System-Model Development for Continuous Drug Substance Manufacturing Process
Boung Wook Lee, GlaxoSmithKline; Kehua Yin, GlaxoSmithKline; Alexander O'Brien, GlaxoSmithKline; Yangmu C. Liu, GlaxoSmithKline; Eric Ricci, GlaxoSmithKline; Brian Roesch, GlaxoSmithKline; Kevin Splaine, GlaxoSmithKline
626e
An Industrial Application of Parameter Estimation of Biocatalytic Transaminase Reactions
Javier Magano, Pfizer Inc.; David Damon, Pfizer Inc.; John Wong, Pfizer Inc.; Steven M. Guinness, Pfizer Inc.; Ke Wang, Pfizer Inc.; Jason Mustakis, Pfizer Inc.; Lu Han, Pfizer Inc.
626f
Investigating the Impact of Water on the Energetics and Kinetics of a Reductive Amination Reaction – a Computational and Experimental Approach
Aikaterini Diamanti, CUCEI, Universidad de Guadalajara; Carla Luciani, Eli Lilly and Company; Jonas Y. Buser, Eli Lilly and Company; Amparo Galindo, Imperial College London; Claire S. Adjiman, Imperial College London
Abstract Submissions Closed
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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