PAT Applied in Biopharmaceutical Process Development And Manufacturing
eBook - PDF

PAT Applied in Biopharmaceutical Process Development And Manufacturing

An Enabling Tool for Quality-by-Design

  1. 327 pages
  2. English
  3. PDF
  4. Available on iOS & Android
eBook - PDF

PAT Applied in Biopharmaceutical Process Development And Manufacturing

An Enabling Tool for Quality-by-Design

About this book

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 comp

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Yes, you can access PAT Applied in Biopharmaceutical Process Development And Manufacturing by Cenk Undey, Duncan Low, Jose C. Menezes, Mel Koch in PDF and/or ePUB format, as well as other popular books in Medicine & Pharmacology. We have over one million books available in our catalogue for you to explore.

Information

Publisher
CRC Press
Year
2011
Print ISBN
9781439829455
eBook ISBN
9781439829462
Edition
1
Subtopic
Pharmacology

Table of contents

  1. Front Cover
  2. Dedication
  3. Contents
  4. Foreword
  5. Introduction
  6. Contributors
  7. Chapter 1: Scientific and Regulatory Overview of Process Analytical Technology in Bioprocesses
  8. Chapter 2: Strategic Vision for Integrated Process Analytical Technology and Advanced Control in Biologics Manufacturing
  9. Chapter 3: Multivariate Techniques in Biopharmaceutical Process Development
  10. Chapter 4: Analysis, Monitoring, Control, and Optimization of Batch Processes: Multivariate Dynamic Data Modeling
  11. Chapter 5: Multivariate Data Analysis in Biopharmaceuticals
  12. Chapter 6: Process Analytical Technology Advances and Applications in Recombinant Protein Cell Culture Processes
  13. Chapter 7: Process Analytical Technology Applied to Raw Materials
  14. Chapter 8: Process Analysis Technology for Enhanced Verification of Bioprocess System Cleaning
  15. Chapter 9: Cell Culture Process Analytical Technology Multiplexing Near-Infrared
  16. Chapter 10: Process Analytical Technology for Bioseparation Unit Operations
  17. Chapter 11: Process Analytical Technology Use in Biofuels Manufacturing
  18. Chapter 12: Application of Microreactors for Innovative Bioprocess Development and Manufacturing
  19. Chapter 13: Real-Time Monitoring and Controlling of Lyophilization Process Parameters through Process Analytical Technology Tools
  20. Chapter 14: Process Analytical Technology's Role in Operational Excellence
  21. Chapter 15: Conclusions, Current Status, and Future Vision of Process Analytical Technology in Biologics