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


Description:
Real time analysis with PAT systems has been widely applied in the pharmaceutical industry in recent years. This session focuses on a few of the many successful examples showing how and why PAT systems enhances process understanding, robustness and performance for both drug substance and drug product. Innovative rather than traditional applications of PAT demonstrating the value of qualitative or quantitative method development for better drug process monitoring and control will be featured. For instance, how chemometrics, or data management can be leveraged for optimized utilization of real time process information.

Sponsor:
Pharmaceutical Discovery, Development and Manufacturing Forum
Co-Sponsor(s):
Pharmaceuticals (15B)


Chair:
Nima Yazdanpanah
Massachusetts Institute of Technology
Department of Chemical Engineering
Cambridge, MA
Email: nima@mit.edu

Co-Chair:
Shujauddin M. Changi
Student
University of Michigan
Chemical Engineering
2300 Hayward Street
Ann Arbor, MI
48109
Email: smchangi@lilly.com


Papers:
Introductory Remarks
565a
Residence Time Distribution and Segregation Studies Trough Real Time Measurements By Near Infrared Spectroscopy
Andrés D. Román-Ospino, Rutgers University; Sarang Oka, Rutgers, The State University of New Jersey; Sara Moghtadernejad, Rutgers University; M. Sebastian Escotet-Espinoza, Rutgers, The State University of New Jersey; Ravendra Singh, Rutgers, The State University of New Jersey; Rohit Ramachandran, Rutgers, The State University of New Jersey; Marianthi Ierapetritou, Rutgers, The State University of New Jersey; Fernando Muzzio, Rutgers, The State University of New Jersey
565b
Use of Process Analytical Technology (PAT) in Advanced Manufacturing Process Monitoring and Control: Scientific Considerations and Regulatory Challenges
Huiquan Wu, FDA/CDER
565c
3D Raman Imaging: A Method to Study the Effects of Lubrication on the Microstructure of Tablets
Shashwat Gupta, Rutgers University; Savitha Panikar, Rutgers, the State University of New Jersey; Fernando J. Muzzio, Rutgers, The State University of New Jersey
565d
Development and Validation of an in-Line NIR Spectroscopic Method for Continuous Blend Potency Determination in the Feed Frame of a Tablet Press
Fien De Leersnyder, Ghent University; Elisabeth Peeters, Ghent University; Djalabi Hasna, Ghent University; Valérie Vanhoorne, Ghent University; Bernd Van Snick, Ghent University; Ke Hong, Pfizer, Inc.; Steve Hammond, Pfizer, Inc.; Chris Vervaet, Ghent University; Thomas De Beer, Ghent University
565e
Identification of Key/Non-Key Process and Model Parameters of Polishing Chromatography, Primary Containers and Autoinjectors Using Mechanistic Models
Pablo A. Rolandi, Amgen Inc.; Fabrice Schlegel, Amgen Inc
565f
In-Situ Agglomeration Measurement during Kdp Crystallization Based on Double-View Image Analysis
Yan Huo, Dalian University of Technology; Tao Liu, Dalian University of Technology; Cai Y. Ma, University of Leeds; Xue Z. Wang, The University of Leeds
565g
Progress in Industrial Implementation of Optical Coherence Tomography (OCT) for Real-Time Evaluation of Pharmaceutical Coating Processes
Patrick R. Wahl, Research Center Pharmaceutical Engineering GmbH; Matthias Wolfgang, RCPE GmbH; Anna Peter, RCPE GmbH; Andrea V. Raffa, Phyllon GmbH; Phillip Clarke, RCPE GmbH; Stephan Sacher, Research Center Pharmaceutical Engineering; Johannes G. Khinast, Graz University of Technology
Concluding Remarks
Abstract Submissions Closed
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