Session: Applications of PAT In a Manufacturing Setting (2011 Annual Meeting)

Wednesday, October 19, 2011: 8:30 AM

Symphony III (Hilton Minneapolis)

Description:

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.

Sponsor:

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Co-Sponsor(s):

Pharmaceuticals (15b)

Chair:

David Unger
Email: dunger@cephalon.com

Co-Chair:

Mark A. LaPack
Email: lapackma@lilly.com

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

8:30 AM

Welcoming Remarks

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

9:20 AM

(432c) PAT Application and Validation of Online Particle Sizing Measurement for Controlling a Critical Quality Attribute
Kevin J. Bittorf

9:40 AM

(432d) Experimental and Theoretical Study of Lyophilization From a Packing of Vials: Using of Tunable Diode Laser Absorption Spectroscopy (TDLAS) for Process Monitoring and Model Calibration
Pavol Rajniak, Cassandra Mifkovich and Leon Farber

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

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

10:59 AM

Concluding Remarks

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

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