PAT Applied in Biopharmaceutical Process Development And Manufacturing An Enabling Tool for Quality-by-Design

Foreword

Introduction
Mel Koch, Ray Chrisman, Duncan Low

CHAPTER 1: Scientific and Regulatory Overview of PAT in Bioprocesses
Rakhi B. Shah, Kurt A. Brorson, Erik K. Read, Jun T. Park, Christopher Watts, Mansoor A. Khan
Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, USA

CHAPTER 2: A Strategic Vision for Integrated PAT and Advanced Control in Biologics Manufacturing
Melissa M. St. Amand, Peter G. Millili, Meghan M. McCabe, Babatunde A. Ogunnaike
University of Delaware, USA

CHAPTER 3: Multivariate Techniques in Biopharmaceutical Process Development
Jeremy S. Conner
Amgen, Inc., USA

CHAPTER 4: Analysis, Monitoring, Control and Optimization of Batch Processes: Multivariate Dynamic Data Modeling
Theodora Kourti
GlaxoSmithKline, UK

CHAPTER 5: Multivariate Data Analysis in Biopharmaceuticals
Joydeep Ganguly*, Louis Obando**, John P. Higgins**, Seongkyu Yoon***
* Biogen-Idec Corp., USA, ** Merck Sharpe and DohmeCorp., USA, *** University of Massachusetts, Lowell, USA

CHAPTER 6: PAT Advances and Applications in Recombinant Protein Cell Culture Processes
Ana Veronica Carvalhal , Victor M. Saucedo
Genentech, Inc., USA

CHAPTER 7: PAT Applied to Raw Materials
Erik Skibsted
Novo Nordisk, Denmark

CHAPTER 8: PAT for Enhanced Verification of Bio-Process System Cleaning
Peter K. Watler*, Keith Bader*, John M. Hyde*, Shuichi Yamamoto**
*Hyde Engineering + Consulting, Inc., USA, **Yamaguchi University, Ube, Japan

CHAPTER 9: Cell Culture PAT Multiplexing NIR
Mariana L. Fazenda, Linda M. Harvey, Brian McNeil
University of Strathclyde, Scotland, UK

CHAPTER 10: Process Analytical Technology (PAT) for Bioseparation Unit Operations
A. S. Rathore, V. Ghare, and R. Bhambure
Department of Chemical Engineering, Indian Institute of Technology, New Delhi, India　　

CHAPTER 11. PAT Use in Biofuels Manufacturing
Pedro Felizardo, José C. Menezes, M. Joana Neiva-Correia
Technical University of Lisbon, Lisbon, Portugal

CHAPTER 12. Application of Micro Reactors for Innovative Bioprocess Development and Manufacturing
Seth T. Rodgers and A. Peter Russo
Seahorse Bioscience, San Francisco, CA, USA

CHAPTER 13: Real-time Monitoring and Controlling of Lyophilization Process Parameters through PAT Tools
Feroz Jameel*, William J. Kessler**
*Amgen, Inc., USA **Physical Sciences Inc., USA

CHAPTER 14: Process Analytical Technologies’ Role in Operational Excellence
Fetanet Ceylan Erzen*, Manbir Sodhi**
*Amgen, Inc., USA, **University of Rhode Island, USA

CHAPTER 15: Conclusions, Current Status and Future Vision of PAT in Biologics
Duncan Low*, Ray Chrisman**
*Amgen Inc., USA, **University of Washington, USA

Biography

Dr. Cenk Undey joined Process Development at Amgen in 2003, where he currently leads the Process and Systems Analysis in Global Process Engineering & Product Engineering group. His division is responsible for providing data management across product lifecycles, developing and deploying advanced real-time multivariate monitoring and control technologies, supporting process monitoring programs and systems, conducting manufacturing process analysis via advanced data analytical methods, and applying systems theory for process troubleshooting and optimization.He led the development and implementation of Multivariate Data Analysis and Real-time Multivariate Statistical Process Monitoring technology in cGMP for use in manufacturing floor during his tenure at Amgen, resulting in significant process improvements. Dr. Undey has industrial experience with PAT tools currently in use in bio/pharmaceuticals manufacturing and is on the steering committee of Pharmaceutical Process Analytics Roundtable. He holds B.Sc., M.Sc. and Ph.D. degrees in Chemical Engineering from Istanbul University, Turkey, and conducted postdoctoral research in Process Modeling, Monitoring and Control group in the Department of Chemical and Biological Engineering at Illinois Institute of Technology, Chicago, USA.Dr. Duncan Low joined the Process Development Department at Amgen in 2003, where he is currently responsible for Materials Science. He leads cross-functional teams for materials and technology evaluation, technology development, and Process Analytical Technology. He is a member of the ISPE Executive Committee for PAT, is a member of USP's Committee of Experts, and chairs the ASTM E55.01 subcommittee which develops consensus standards for Manufacturers of Pharmaceutical Products. Prior to joining Amgen, he held VP positions at Millipore and Pharmacia Biotech. He has extensive experience of the tools currently in use for upstream and downstream