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

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Features

  • Evaluates all data flowing from the bioprocess to facilitate manufacturing excellence and lean manufacturing concepts
  • Uses multivariate data analysis (MVDA) for problem solving and model development at the pilot scale, demonstrating how this knowledge can flow into uses for production control
  • Offers many examples of the ways in which design teams are using PAT to not only speed process development for biopharmaceutical production, but also how it is being used to insure high-quality production with enhanced regulatory compliance
  • Designed for students and others beginning efforts in PAT for QbD purposes

Summary

As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development.

Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time.

Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.

Table of Contents

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

Editor Bio(s)

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 processing and has worked closely with applications development throughout the industry. He has an M.A. in Biochemistry from the University of Cambridge and a Ph.D. in Microbiology from the University of Glasgow.

Prof. Jose Cardoso de Menezes coordinates a Systems Engineering group at the Technical University of Lisbon (IST), Centre for Biological and Chemical Engineering, working in PAT, Chemometrics and Multivariate Statistics for over 10 years. He has a Chemical Engineering degree, M.A. in Catalysis, Ph.D. in Biochemical Engineering, and a Post-Doctorate in advanced monitoring of bioprocesses. Currently, he is an Invited Associate Professor of Faculty at Pharmacy of Lisbon University (FPLU) and has recently started his own company to exploit PAT implementations in industry. Also, he founded and coordinated for the past 3 years a Masters Program in Pharmaceutical Engineering, jointly taught by IST and FPLU, which covers PAT and PAT disciplines such as QbD, DOE, NIR and other monitoring, modeling and control techniques. He is a member of ISPE, as well as other organizations, has published extensively, and taught many Ph.D. and M.Sc. students on the above subjects.

Dr. Melvin V. Koch is the executive director of the Center for Process Analysis and Control (CPAC) and Affiliate Professor of Chemical Engineering at the University of Washington in Seattle. He received a B.A. in Chemistry and Mathematics from St Olaf College, M.S. in biochemistry, and Ph.D. in Organic Medicinal Chemistry from the University of Iowa. Dr. Koch previously worked for The Dow Chemical Company in process research and analytical chemistry, achieving the level of Global Director of Analytical Sciences. Currently, he is active with coordinating developments in the field of process analytical technology (PAT) between industry, government agencies, and academia. Dr. Koch has served on the FDA advisory committee to the Office of Pharmaceutical Sciences and on review committees of several US National Laboratories.