Session: Pharmaceutical Process Development & Pilot Plants (2012 Annual Meeting)

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
Abbott Laboratories
Process Research & Development
1401 Sheridan Rd
North Chicago, IL 60048
Phone Number: 847-937-6100
Email: james.marek@abbott.com

Co-Chair:

Adam S. Butterbaugh, P.E.
Consultant Engineer
Eli Lilly & Co.
Chemical Process R&D
DC 4813
Indianapolis, IN 46285
Email: butterbaughas@lilly.com

Papers:

107a

Strategies in Advancing the Pharmaceutical Pipeline - an Overview of API Pilot Plant
Jim Ratway, Abbott

107b

A Pharmaceutical Engineering Process/Product Life-Cycle Approach to Drug Product Development and Manufacturing
Jose C. Menezes, Research Center Pharmaceutical Engineering GmbH; Stephan Sacher, Research Center for Pharmaceutical Engineering; Georg Scharrer, Research Center for Pharmaceutical Engineering; Stefan Leitgeb, Research Center Pharmaceutical Engineering GmbH; Christine Voura, Research Center Pharmaceutical Engineering (RCPE); Simon D. Fraser, Research Center Pharmaceutical Engineering (RCPE); Johannes G. Khinast, Research Center Pharmaceutical Engineering GmbH

107c

Leveraging HPLC Data in a QbD Approach, for Right-First Time Scale-up of API Reaction Steps
Wilfried Hoffmann, Scale-up Systems; Andrew Bird, Scale-up Systems; Peter Clark, DynoChem Inc

107d

Continuous Distillation Operations and Application of the Wiped Film Evaporator (WFE) to Pharmaceutical Pilot Plant Processing
Anne Mohan, Merck & Co., Inc.; Elizabeth Fisher, Merck & Co., Inc.; Rukyah Hennessey, Merck & Co., Inc.; Joe Kukura, Merck & Co., Inc.; Dave Lashen, Merck & Co., Inc.; Crystal Miranda, Merck & Co., Inc.; Glenn Spencer, Merck & Co., Inc.; Michael Ward, Merck & Co., Inc.; Ming Yue, Merck & Co., Inc.; George Zhou, Merck & Co., Inc.

Break

107f

Scale-up of Superficial Fluidization Air Velocity for a Pharmaceutical Fluid Bed Granulation
Brendon G. Ricart, Merck & Co.; Alan R. Silverman, Merck & Co., Inc.; Kristin J. Ploeger, Merck & Co; Edward J. Smith, Merck & Co., Inc.

107g

Experimental Determination of Maximum Shear Stress in Multiphase Flow – From Micro Scale to Pilot Scale Reactors
Thomas K. Villiger, ETH Zurich; Miroslav Soos, ETH Zurich; Massimo Morbidelli, ETH Zurich

See more of this Group/Topical: Process Development Division

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