470 Multivariate Experimentation and Modeling for Pharmaceutical Products and Processes


Description:
This session illustrates the advantages of integrating multivariate experimentation and modeling concepts into product and process development to support pharmaceutical manufacturing. Drug substance and drug product applications from industry and academia are both considered for this session track. Contributions that incorporate multivariate process modeling with experimental designs to optimize product and process performance in drug substance and/or drug product manufacturing are encouraged for submission.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Systems and Process Design (10A), Pharmaceuticals (15B)


Chair:
Yuesheng Ye
Food and Drug Administration

Email: Yuesheng.Ye@fda.hhs.gov

Co-Chair:
Nil Tandogan
Associate Sr Consultant Engineer
Eli Lilly and Company
360 Huntington Avenue, 313 SN
Indianapolis, IN
02115
Email: tandogan_nil@lilly.com


Papers:
470a
Accelerating High-Throughput Experimentation with Templated Statistical Analysis
Jacob Albrecht, Bristol-Myers Squibb; Victor W. Rosso, Bristol-Myers Squibb; Eric M. Saurer, Bristol-Myers Squibb Co.; Jose E. Tabora, Bristol-Myers Squibb; Brendan C. Mack, Bristol-Myers Squibb; Frederick Roberts, Bristol-Myers Squibb; Grace Chiou, Bristol-Myers Squibb; Jacob Janey, Bristol-Myers Squibb
470b
Process Fingerprinting Tools in the Development of an Alkylation Reaction
Kevin Stone, Merck & Co., Inc.; Brian M. Wyvratt, Merck & Co., Inc.; Emmanuel Adachi, Merck & Co., Inc.; Marguerite Mohan, Merck & Co., Inc.; Jonathan P. McMullen, Merck & Co. Inc.
470c
Reactor Design for Continuous Synthesis of Pharmaceutical Intermediates: Correlation of Computational Fluid Dynamics and Design of Experiment Approaches
Thomas D. Roper, Virginia Commonwealth University; Michael J. Bortner, Virginia Polytechnic Institute and State University; Cameron Armstrong, Virginia Commonwealth University; Cailean Pritchard, Virginia Polytechnic Institute and State University; Daniel Cook, Virginia Commonwealth University; Mariam Ibrahim, Virginia Commonwealth University; Bimbisar Desai, Virginia Commonwealth University; Yizheng Chen, Virginia Commonwealth University; Brian Marquardt, MarqMetrix; Patrick Whitham, University of Washington; Thouakesseh Zoueu, Institut National Polytechnique Félix HOUPHOUËT
470d
Optimal Design of Experiments for Building Fundamental Models of Pharmaceutical Production Processes
Ali Shahmohammadi, Queens University; Kimberley B. McAuley, Queen's University
470e
Model-Based Design of Experiments for Pharmaceutical Reaction Development
Kevin Stone, Merck & Co., Inc.; Jonathan P. McMullen, Merck & Co. Inc.; Dan Willard, Merck & Co., Inc.
470f
Defining the Optimal Operating Window for Pharmaceutical Reactions Using the Dynamic Response Surface Methodology for All Measured Species
Yachao Dong, Tufts University; Christos Georgakis, Tufts University; Jason Mustakis, Pfizer Inc.; Joel M. Hawkins, Pfizer Inc.; Jonathan P. McMullen, Merck & Co. Inc.; Shane T. Grosser, Merck & Co., Inc.
470g
Sensitivity Analysis and Identification of Feasible Region of a Wet Granulation Continuous Pharmaceutical Manufacturing Process
Nirupaplava Metta, Rutgers, The State University of New Jersey; Marianthi Ierapetritou, Rutgers, The State University of New Jersey; Rohit Ramachandran, Rutgers, The State University of New Jersey
Abstract Submissions Closed
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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