107 Pharmaceutical Process Development & Pilot Plants

Monday, October 29, 2012: 12:30 PM
Shadyside (Omni )
Description:
Pharmaceutical pilot plants are a valuable resource for ensuring efficient process scale-up and tech transfer to commercial manufacturing, as well as providing key deliveries of API and Drug Product for clinical supply. This session will showcase a variety of strategies for pilot plant design, operation, and even outsourcing that enhance pharmaceutical process development. Case studies on implementation of Process Analytical Technologies (PAT) in a pilot plant environment are also especially encouraged.

Sponsor:
Pilot Plants
Co-Sponsor(s):
Pharmaceuticals (15b)

Chair:
James Marek
Email: james.marek@abbott.com

Co-Chair:
Adam S. Butterbaugh, P.E.
Email: butterbaughas@lilly.com

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


12:30 PM
(107a) Strategies in Advancing the Pharmaceutical Pipeline - an Overview of API Pilot Plant
Jim Ratway

12:51 PM
(107b) A Pharmaceutical Engineering Process/Product Life-Cycle Approach to Drug Product Development and Manufacturing
Jose C. Menezes, Stephan Sacher, Georg Scharrer, Stefan Leitgeb, Christine Voura, Simon D. Fraser and Johannes G. Khinast

1:12 PM
(107c) Leveraging HPLC Data in a QbD Approach, for Right-First Time Scale-up of API Reaction Steps
Wilfried Hoffmann, Andrew Bird and Peter Clark
File available
1:33 PM
(107d) Continuous Distillation Operations and Application of the Wiped Film Evaporator (WFE) to Pharmaceutical Pilot Plant Processing
Anne Mohan, Elizabeth Fisher, Rukyah Hennessey, Joe Kukura, Dave Lashen, Crystal Miranda, Glenn Spencer, Michael Ward, Ming Yue and George Zhou

1:54 PM
Break

2:19 PM
(107f) Scale-up of Superficial Fluidization Air Velocity for a Pharmaceutical Fluid Bed Granulation
Brendon G. Ricart, Alan R. Silverman, Kristin J. Ploeger and Edward J. Smith

2:40 PM
(107g) Experimental Determination of Maximum Shear Stress in Multiphase Flow – From Micro Scale to Pilot Scale Reactors
Thomas K. Villiger, Miroslav Soos and Massimo Morbidelli
See more of this Group/Topical: Process Development Division
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