Session: Applications of PAT in a Manufacturing Setting (2010 Annual Meeting)

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. Authors are encouraged to submit papers discussing case studies and value-added applications of PAT in manufacturing settings as well as challenges overcome and lessons learned while implementing PAT in a commercial product.

Sponsor:

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

Co-Sponsor(s):

Pharmaceuticals (15b)

Chair:

David Unger
Cephalon
Philadelphia, PA 19380-4249
Phone Number: 610-738-6838
Email: dunger@cephalon.com

Co-Chair:

Simon D. Fraser
Research Center Pharmaceutical Engineering (RCPE)
Graz Phone Number: +43-316-873-9707
Email: simon.fraser@rcpe.at

Papers:

Welcoming Remarks

510a

Quality-by-Design (QbD): Integration of Design of Experiments (DOE) and Real-Time PAT Monitoring for Pharmaceutical Powder Blending Process Evaluation
Huiquan Wu, FDA; Mansoor A. Khan, Food and Drug Administration

510b

Raman Spectroscopy Combined with Small and Wide Angle X-Ray Scattering as a Non Destructive Quality Control Tool for Powder Compression Analytics in Pharmaceutical Applications
Nicolas Heigl, Research Center Pharmaceutical Engineering GmbH; Johannes G. Khinast, Research Center Pharmaceutical Engineering (RCPE)

510c

On-Line Monitoring of Roller Compaction Ribbon Density Using NIR Spectroscopy
Ryan McCann, Purdue University; Ariel Muliadi, Purdue University; Janne Paaso, VTT Technical Research Centre of Findland; James Litster, Purdue University; Rodolfo Pinal, Purdue University

510d

Real-Time Monitoring of Pharmaceutical Manufacturing Processes with a Multiplexed Optical Fiber Probe NIR-Setup
Nikolaus Balak, Research Center Pharmaceutical Engineering GmbH; Daniel M. Koller, Research Center Pharmaceutical Engineering GmbH; Johannes Khinast, Graz University of Technology

Break

510e

On-Line Blend Monitoring of Pharmaceutical Materials Using Multiple NIR Sensors
Benoit Igne, Duquesne University; Zhenqi Shi, Duquesne University; Carl A. Anderson, Duquesne University; James K. Drennen III, Duquesne University

510f

Drying Mechanism and Aggregate Formation of API
Daniel Hsieh, Bristol-Myers Squibb Company; Joshua Engstrom, Bristol-Myers Squibb Company; Deniz Erdemir, Bristol-Myers Squibb Company; Steven Chan, Bristol-Myers Squibb Company; Steve S. Y. Wang, Bristol-Myers Squibb Company; Shih-Ying Chang, Bristol-Myers Squibb Company; Chiajen Lai, Bristol-Myers Squibb Company; San Kiang, Bristol-Myers Squibb Company

510g

Real-Time Monitoring of Continuous Processes with Spectroscopic PAT-Tools
Daniel M. Koller, Research Center Pharmaceutical Engineering GmbH; Nikolaus Balak, Research Center Pharmaceutical Engineering GmbH; Simon D. Fraser, Research Center Pharmaceutical Engineering GmbH; Johannes G. Khinast, Graz University of Technology

Concluding Remarks

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

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