Pat Applied in Biopharmaceutical Process Development and Manufacturing: An Enabling Tool for Quality-By-Design (Hardcover)

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, Jose 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