438 Multivariate Modeling and Quality-by-Control Approaches for Pharmaceutical Processes


Description:
This session is focused on the advances in the application of multivariate statistical approaches (both latent variable and other approaches) to support the development and manufacture of medicine through the reduction of variability or deviation; i.e. increasing process robustness. These approaches can include data visualization, statistical process control algorithms, chemometrics, and chemical or biochemical process modeling for drug product and drug substance applications. Contributions for both industry and academia are encouraged.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Data and Information Systems (10E), Pharmaceuticals (15B)


Chair:
Jacob Albrecht
Senior Research Investigator
Bristol-Myers Squibb Company
One Squibb Drive
New Brunswick, NJ
08903
Email: jacob.albrecht@bms.com

Co-Chair:
Kevin Seibert
Sr Eng Advisor
Eli Lilly & Company
SMDD
Indianapolis, IN
46285
Email: seibertkd@lilly.com


Papers:
438a
A Method to Reduce Dimensionality of Powder Flow Characterization
Yifan Wang, Food and Drug Administration; Kushal Dhinoja, Rutgers University; Fernando Muzzio, Rutgers, the State University of New Jersey; Celia N. Cruz, U.S. Food and Drug Administration
438b
Using Mechanistic Modeling of Chromatography to Increasing Process Understanding
Tim Fattor, KBI Biopharma, Inc.; Stephen Hunt, KBI Biopharma, Inc.; Jonathan Rocher, KBI Biopharma, Inc.; Robert Todd, KBI Biopharma, Inc.
438c
Multivariate Monitoring of a Continuous Manufacturing Process for API Synthesis: Enhancing the Power of Real Time Data
Melanie Dumarey, GlaxoSmithKline; Martin Hermanto, GlaxoSmithKline
438d
Global System Analysis of Interconnected Flow Sheet Models for Drug Product Manufacturing to Performance
Pankaj Doshi, Worldwide Research and Development, Pfizer Inc.; Marta Moreno Benito, Pfizer; Conrad Davies, Pfizer
438e
Closed Loop Dynamics of Ribbon Density in a Dry Granulation Process
Sudarshan Ganesh, Purdue University; Mariana Moreno, Purdue University; Qinglin Su, Purdue University; Zoltan K. Nagy, Purdue University; G. V. Reklaitis, Purdue University
438f
Integrated Control and Data Management System for Continuous Pharmaceutical Manufacturing Process
Ravendra Singh, Rutgers, The State University of New Jersey; Fernando J. Muzzio, 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
438g
In silico Process Characterization of Drug Product Filling Operations: Predicting Quality Attributes from First Principles
Will Johnson, Amgen; Pablo Rolandi, Amgen
Abstract Submissions Closed
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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