Session: Model Based Qbd in Drug Substance (2009 Annual Meeting)

Wednesday, November 11, 2009: 12:30 PM

Hermitage C (Gaylord Opryland Hotel)

Description:

This session focuses on the use of mathematical models and simulation in establishing a Design Space in support of QbD for a Drug Substance Operation. Authors are invited to share the challenges in the model development and validation, and the strategy used for QbD.

Sponsor:

Topical I: Comprehensive Quality by Design to Develop and Manufacture Pharmaceutical Products

Co-Sponsor(s):

Systems and Process Design (10a), Process Development Division (12), Pharmaceuticals (15b)

Chair:

Shekhar K. Viswanath
Email: viswanathsh@lilly.com

Co-Chair:

Stelios C. Tsinontides
Email: stsinont@cephalon.com

12:30 PM

(417a) Model-Based Quality by Design Applied to An API Process
Justin L. Burt, James Bergum, Alan Braem, Antonio Ramirez, Lucius Rossano, Jose Tabora and Srinivas Tummala

12:55 PM

(417b) Applications of Quality by Design Principles Utilizing Process Modeling and PAT in the Development of An API Process
Christopher L. Burcham, Joeseph R. Martinelli and Mark A. LaPack

1:20 PM

(417c) Enhancing Process Understanding around Impurities Formation in API Intermediate Synthesis Via Kinetic Modeling & CFD
Samrat Mukherjee, Shailendra V. Bordawekar and Nandkishor K. Nere

1:45 PM

(417d) An Integrated High-Throughput Experimentation and Semi-Empirical Modeling Approach to Building Process Knowledge in Pharmaceutical Process Development
Alexander J. Marchut, Jun Qiu, Olav K. Lyngberg and A. Erik Rubin

2:10 PM

(417e) Numerical Simulation of Mixing and Drying of Pharmaceutical Particles in a Bubbling Fluidized Bed Reactor
Jungkee Jang, Cezar A. Rosa and Hamid Arastoopour

2:35 PM

(417f) Design Space, Models and Model Uncertainty
Constantinos C. Pantelides, Nilay Shah and Claire S. Adjiman

See more of this Group/Topical: Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture