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