99 Model Based QbD in Drug Substance or Drug Product Development

Monday, October 29, 2012: 12:30 PM
Allegheny II (Westin )
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
Email: WONG_SZE_WING@LILLY.COM

Co-Chair:
Brian C. Anderson
Email: brian.c.anderson@abbvie.com

- indicates paper has an Extended Abstract file available on CD.

File available
12:30 PM
(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

12:55 PM
(99b) Modeling the Dynamics of the Film Coating Operation for Pharmaceutical Tablets
Salvador García-Muñoz, Mariana Moreno, Alejandro Cano and Simon Leyland

1:20 PM
(99c) Modeling of Fluid Bed Granulation Process for Aqueous Systems
Rajan Gupta

1:45 PM
(99d) Plant-Wide Hybrid Model Predictive Control of a Continuous Pharmaceutical Tablet Manufacturing Process Via Direct Compaction
Ravendra Singh, Marianthi Ierapetritou and Rohit Ramachandran

2:10 PM
(99e) PAT for Pharmaceutical Extrusion Monitoring and Supervisory Control
Stephan Sacher, Patrick Wahl, Daniel Markl, Daniel Treffer, Jose C. Menezes, Gerold Koscher, Eva Roblegg and Johannes G. Khinast
File available
2:35 PM
(99f) Scientific Validation of THz Spectroscopic Measurement and Its Pharmaceutical Process Analytical Technology (PAT) Applications: Case Studies of First Principles Modeling Approach
Huiquan Wu and Mansoor A. Khan
See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
<< Previous Session | Next Session >>