605 PAT for Process Understanding, Reduced Testing, and Elucidation of Fundamental Phenomena in Drug Product/Substance Development

Wednesday, November 11, 2015: 3:15 PM - 5:45 PM
Ballroom D (Salt Palace Convention Center)

Description:
This session focuses on how PAT systems have been used to improve the process performance during drug substance and drug product development. The session welcomes presentations that describe successful as well as unsuccessful applications of PAT technologies for process understanding. Novel applications of PAT for process understanding are very welcome. The session is also interested in the use of PAT for qualitative but especially quantitative analysis of processes, chemometrics and PAT and the application of PAT for understanding process scale up. Presentations in the application of PAT Data Management systems to obtain Process Understanding are also welcome.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pharmaceuticals (15B)
Chair:
Mary T. am Ende Email: mary.t.am.ende@pfizer.com
Co-Chair:
Anil Rane Email: anil.rane@pfizer.com


3:15 PM
(605a) Development of a Novel PAT for in-Line Measurement of Powder Dynamic Density inside Feed Frame of Rotary Tablet Presses
Mehrdad Kheiripour Langroudi, Amy L. Quach, Utsav Patel, Robert F. Meyer and W. Mark Eickhoff


3:35 PM
(605b) Development of a Control Strategy for Continuous Manufacturing of Solid Dosage Forms
Stephan Sacher, Isabella Aigner, Patrick R. Wahl, Peter Kleinebudde, Hubertus Rehbaum and Johannes G. Khinast


3:55 PM
(605c) Investigation of Segregation Effects in a Direct Compaction Process Via Multipoint NIR Monitoring and NIR Chemical Imaging
Stephan Sacher, Patrick R. Wahl, Marcos Llusá and Johannes G. Khinast


4:15 PM
(605d) Characterization of Tablet Core and Coating Roughness By Means of Optical Coherence Tomography
Daniel Markl, Stephan Sacher, Heinz Pichler, Paul Rinner and Johannes G. Khinast


4:35 PM
(605e) In-Line Monitoring of a Pharmaceutical Fluid-Bed and Pan Coating Process By Optical Coherence Tomography
Daniel Markl, Stephan Sacher and Johannes G. Khinast


4:55 PM
(605f) Development and Demonstration of a Suite of Tools Aimed at Process Development Intensification and Efficient Experimentation Practices
Shane T. Grosser, Jon Jurica and Jonathan McMullen


5:15 PM
(605g) Spectroscopy Assisted Process Design for Complex Multi-Phase Organic Reactions
Dimitri Skliar, Jeffrey A. Nye, Mathew Hickey, Richard Fox and David Ayers
See more of this Group/Topical: Pharmaceutical Discovery, Development and Manufacturing Forum
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