Session: Application of PAT in the Manufacturing Setting (2012 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 (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):

Systems and Process Control (10B)

Chair:

Stelios Tsinontides
Senior Director, US Technical Operations
Teva Pharmaceuticals
US Technical Operations
145 Brandywine Parkway
West Chester 19380
Email: stsinont@cephalon.com

Co-Chair:

Sharmista Chatterjee
CMC Lead for QbD
FDA
Ondqa/Cder/FDA
Silver Spring, MD 20993
Phone Number: 301-796-2252
Email: sharmista.chatterjee@fda.hhs.gov

Papers:

401a

Process Understanding Tools in PAT Implementations
Joao Machado, 4Tune Engineering Ltd - Technology Services & Products; Tiago Robalo, 4Tune Engineering Ltd - Technology Services & Products; Pedro Felizardo, 4Tune Engineering Ltd - Technology Services & Products; Jose Menezes, Research Center Pharmaceutical Engineering GmbH

Break

401c

An Integrated Process Analytical Technology (PAT) Approach to Examine the Effect of Temperature On Nucleation Kinetics of a Dynamic Pharmaceutical Co-Precipitation Process
Huiquan Wu, FDA; Maury White, FDA; Ryan Foringer, FDA CDER; Mansoor A Khan, FDA

401d

Making PAT an Integral and Sustained Part of Manufacturing Operations
John O'Reilly, Roche

401e

Design and Implementation of An Efficient Control System in a Continuous Pharmaceutical Manufacturing Process Via Roller Compaction
Ravendra Singh, Rutgers, The State University of New Jersey; Marianthi Ierapetritou, Rutgers, The State University of New Jersey; Rohit Ramachandran, Rutgers, The State University of New Jersey

401f

Near Infrared Spectroscopy (NIRS): An Enabling Tool for Pharmaceutical Quality by Design (QbD)
K. Geoffrey Wu, Food and Drug Administration; Suhas Patankar, Food and Drug Administration; Lane V. Christensen, Food and Drug Administration; Robert A. Lionberger, Food and Drug Administration; Lawrence X. Yu, Food and Drug Administration

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

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