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Model Based QbD in Drug Substance or Drug Product Development


Description:
Understanding the relationships between the manufacturing process and product quality attributes is essential to implementing Quality-by-Design (Qbd), leading to robust processes and improved performance through operation in an appropriate design space. Speakers are invited to present models based on first-principles, statistical (including multivariate), or semi-empirical methods, and their use to develop design spaces during API process and drug product development. Submissions that address model verification or application at scale are particularly welcome.

Sponsor:
Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Co-Sponsor(s):
Systems and Process Design (10A)


Chair:
Sze Wing (Candice) Wong
Eli Lilly and Company
Chemical Process R&D
Lilly Research Labs South
Indianapolis, IN 46285
Email: WONG_SZE_WING@LILLY.COM

Co-Chair:
Brian C. Anderson
Abbott Laboratories
100 Abbott Park Road
Abbott Park, IL 60064-3500
Email: Brian.C.Anderson@abbott.com


Papers:
99a
Leveraging Models for Process Understanding; Case Studies in O2 Sensitivity of a Pd Catalyzed CN Bond Forming Reaction and Isobutylene Release in a Tertbutyl Deprotection Reaction
Jeremy Merritt, Eli Lilly and Co.
99b
Modeling the Dynamics of the Film Coating Operation for Pharmaceutical Tablets
Salvador García-Muñoz, Pfizer Worldwide Research & Development; Mariana Moreno, Tec de Monterrey; Alejandro Cano, Process Systems Enterprise, Inc.; Simon Leyland, Process Systems Enterprise Inc
99c
Modeling of Fluid Bed Granulation Process for Aqueous Systems
Rajan Gupta, Merck
99d
Plant-Wide Hybrid Model Predictive Control of a Continuous Pharmaceutical Tablet Manufacturing Process Via Direct Compaction
Ravendra Singh, 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
99e
PAT for Pharmaceutical Extrusion Monitoring and Supervisory Control
Stephan Sacher, Research Center Pharmaceutical Engineering GmbH; Patrick Wahl, Research Center Pharmaceutical Engineering GmbH; Daniel Markl, Research Center Pharmaceutical Engineering GmbH; Daniel Treffer, Graz University of Technology; Jose C. Menezes, Research Center for Pharmaceutical Engineering; Gerold Koscher, Research Center Pharmaceutical Engineering GmbH; Eva Roblegg, University of Graz; Johannes G. Khinast, Graz University of Technology
99f
Scientific Validation of THz Spectroscopic Measurement and Its Pharmaceutical Process Analytical Technology (PAT) Applications: Case Studies of First Principles Modeling Approach
Huiquan Wu, FDA; Mansoor A. Khan, FDA
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
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