Applications of PAT In a Manufacturing Setting

Wednesday, October 19, 2011: 8:30 AM
Symphony III (Hilton Minneapolis)

This section focuses on the use of Process Analytical Technologies to monitor, control, and gain a better understanding of Pharmaceutical manufacturing processes at commercial scales (drug products and drug substances (APIs)). Authors are encouraged to submit papers discussing case studies, research, and value-added applications of PAT in manufacturing settings as well as challenges overcome and lessons learned while implementing PAT in pharmaceutical manufacturing operations.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
Pharmaceuticals (15b)

David Unger

Mark A. LaPack

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

8:32 AM
(432a) Taking PAT From the Laboratory to Commercial Manufacturing
Mark A. LaPack, Stephen B. Jeffery, Steven J. Doherty, Joseph R. Martinelli and Christopher L. Burcham

9:00 AM
(432b) Combining Microwave Resonance Technology to Multivariate Data Analysis As a Novel PAT Tool to Improve Process Understanding In Fluid Bed Granulation
Vera Lourenco, Thorsten Herdling, Gabriele Reich, Jose Cardoso Menezes, Dirk Lochmann and Jens Schewitz

10:00 AM
(432e) Optical Coherence Tomography: A New PAT-Tool for Fast and Non-Destructive Analysis of Tablet Coating Quality
Daniel M. Koller, Christoph Schinwald, Otto Scheibelhofer, Michael Leitner and Johannes G. Khinast

10:20 AM
(432f) QbD-Driven PAT Applications for Precision Spray-Coating Development and Control
Charles Miller, Bruce T. Thompson, Fan Zhang-Plasket, Patrick T. Schilling, John Higgins, Gert Thurau, Mano Ramasamy and Eric Ahuja

File available
10:40 AM
(432g) Process Analytical Technology for Recombinant Pandemic Flu Vaccines: Viral Ultrastructure, Aggregation, and Binding
De-Hao Tsai, Daniel Lipin, Suvajyoti Guha, Jeremy Feldblyum, Kenneth D. Cole, Kurt A. Brorson, Michael Zachariah, Michael J. Tarlov, Anton P. J. Middelberg and Leonard F. Pease III