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

Book details
Table of contents
Citations

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, 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
ISBN
9781439829462
Edition
1
Topic
Medicine
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