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

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
Professor
Technical University of Denmark
CAPEC, Department of Chemical and Biochemical Engineering
Søltofts Plads, Building 229
2800 Kgs. Lyngby Phone Number: +45 4525 2882
Email: rag@kt.dtu.dk

Co-chairs:

David J. am Ende and Christopher L. Burcham

Papers:

111a

Modeling Batch Pharmaceutical Reactions by Factor Analysis of Spectral Data
Fredy Afif, Tufts University; Christos Georgakis, Tufts University

111b

Incorporating “Process Efficiency” Attributes and Lean Thinking During API Product Development”
Ken Ryan, Pfizer Pharmaceuticals; Vincent Mc Curdy, Pfizer Pharmaceuticals; Roger Weaver, Pfizer Pharmaceuticals; Garry O'Connor, Pfizer Pharmaceuticals

111c

The Development of the Design Space for Maraviroc API
Garry O'Connor, Pfizer; Ken Ryan, Pfizer Pharmaceuticals

111d

Linking Unit Operations During Design Space Development and Definition
Lynn Conley, Biogen Idec; Leonard Perry, University of San Diego; John Pieracci, Biogen Idec; Matthew Westoby, Biogen Idec

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, FDA; Mansoor A. Khan, Food and Drug Administratin

Break

111f

Synthesis and Steady-State Optimization of a Continuous Pharmaceutical Process
Dimitrios I. Gerogiorgis, Massachusetts Institute of Technology (M.I.T.); Paul I. Barton, Massachusetts Institute of Technology (M.I.T.)

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

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