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

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
Research Advisor
Eli Lilly and Company
Chemical Process R&D
Indianapolis, IN 46285
Phone Number: (317) 277-4511
Email: viswanathsh@lilly.com

Co-Chair:

Stelios C. Tsinontides

Papers:

417a

Model-Based Quality by Design Applied to An API Process
Justin L. Burt, Bristol-Myers Squibb; James Bergum, Bristol-Myers Squibb; Alan Braem, Bristol-Myers Squibb; Antonio Ramirez, Bristol-Myers Squibb; Lucius Rossano, Bristol-Myers Squibb; Jose Tabora, Bristol-Myers Squibb; Srinivas Tummala, Bristol-Myers Squibb

417b

Applications of Quality by Design Principles Utilizing Process Modeling and PAT in the Development of An API Process
Christopher L. Burcham, Eli Lilly and Company; Joeseph R. Martinelli, Eli Lilly and Company; Mark A. LaPack, Eli Lilly and Company

417c

Enhancing Process Understanding around Impurities Formation in API Intermediate Synthesis Via Kinetic Modeling & CFD
Samrat Mukherjee, Abbott Laboratories; Shailendra V. Bordawekar, Abbott Laboratories; Nandkishor K. Nere, Abbott Laboratories

417d

An Integrated High-Throughput Experimentation and Semi-Empirical Modeling Approach to Building Process Knowledge in Pharmaceutical Process Development
Alexander J. Marchut, Bristol Myers Squibb; Jun Qiu, Bristol Myers Squibb; Olav K. Lyngberg, Bristol Myers Squibb; A. Erik Rubin, Bristol Myers Squibb

417e

Numerical Simulation of Mixing and Drying of Pharmaceutical Particles in a Bubbling Fluidized Bed Reactor
Jungkee Jang, Illinois Institute of Technology; Cezar A. Rosa, Illinois Institute of Technology; Hamid Arastoopour, Illinois Institute of Technology

417f

Design Space, Models and Model Uncertainty
Constantinos C. Pantelides, Process Systems Enterprise Ltd.; Nilay Shah, Imperial College London; Claire S. Adjiman, Centre for Process Systems Engineering

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

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