Session: Qbd Across Drug Substance Operations (2009 Annual Meeting)

Monday, November 9, 2009: 12:30 PM

Hermitage D (Gaylord Opryland Hotel)

Description:

This session focuses on work where multiple steps in the drug substance operation are considered simultaneously in a Design Space. Authors are invited to discuss the physical circumstance (how and why the multiple steps are linked) and the tools they used to quantify, visualize and define the design space

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:

Rafiqul Gani
Email: rag@kt.dtu.dk

Co-chairs:

12:30 PM

(111a) Modeling Batch Pharmaceutical Reactions by Factor Analysis of Spectral Data
Fredy Afif and Christos Georgakis

12:50 PM

(111b) Incorporating “Process Efficiency” Attributes and Lean Thinking During API Product Development”
Ken Ryan, Vincent Mc Curdy, Roger Weaver and Garry O'Connor

1:10 PM

(111c) The Development of the Design Space for Maraviroc API
Garry O'Connor and Ken Ryan

1:30 PM

(111d) Linking Unit Operations During Design Space Development and Definition
Lynn Conley, Leonard Perry, John Pieracci and Matthew Westoby

1:50 PM

(111e) Quality-by-Design (QbD): Process Trajectory Development for a Pharmaceutical Co-Precipitation Process Based On An Integrated Real-Time Process Monitoring Strategy
Huiquan Wu and Mansoor A. Khan

2:10 PM

Break

2:20 PM

(111f) Synthesis and Steady-State Optimization of a Continuous Pharmaceutical Process
Dimitrios I. Gerogiorgis and Paul I. Barton

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