Continuous pharmaceutical processing and process analytical technology
Author(s)
Bibliographic Information
Continuous pharmaceutical processing and process analytical technology
(Drugs and the pharmaceutical sciences)
CRC Press, 2023
- : hbk
Available at 2 libraries
  Aomori
  Iwate
  Miyagi
  Akita
  Yamagata
  Fukushima
  Ibaraki
  Tochigi
  Gunma
  Saitama
  Chiba
  Tokyo
  Kanagawa
  Niigata
  Toyama
  Ishikawa
  Fukui
  Yamanashi
  Nagano
  Gifu
  Shizuoka
  Aichi
  Mie
  Shiga
  Kyoto
  Osaka
  Hyogo
  Nara
  Wakayama
  Tottori
  Shimane
  Okayama
  Hiroshima
  Yamaguchi
  Tokushima
  Kagawa
  Ehime
  Kochi
  Fukuoka
  Saga
  Nagasaki
  Kumamoto
  Oita
  Miyazaki
  Kagoshima
  Okinawa
  Korea
  China
  Thailand
  United Kingdom
  Germany
  Switzerland
  France
  Belgium
  Netherlands
  Sweden
  Norway
  United States of America
Note
Includes bibliographical references and index
Description and Table of Contents
Description
Discusses scientific solutions and process analytical technology to enable continuous manufacturing in the development of new drugs.
Includes short stories about how some companies have adopted CM and what their drivers were and what benefits were realized.
Addresses economic and practical considerations, unlike many other technical books.
Emphasizes the practical aspects to give the reader the strategic imperative and technological depth to adopt and implement these technologies.
Highlights the "why" and the "how", focusing on the need analysis and process modeling and process analytical technologies
Table of Contents
Section I: Design and Control: Continuous Manufacturing of Small Molecule Drug Substances and Products
1. A Survey of Continuous API Syntheses: Insights at the Interface of Chemistry and Chemical Engineering.
2. Development of Continuous Pharmaceutical Crystallization.
3. Residence Time Distribution in Continuous Manufacturing.
4. Powder Electrostatics in Continuous Pharmaceutical Manufacturing.
5. Continuous Impregnation Processes
6. Leveraging a mini-batch wise continuous direct compression (CDC) approach to optimize efficiency in process development, on-demand manufacturing and continuous process verification (CPV).
7. Predictive In-Vitro Dissolution for Real-time Release Test (RTRT) for Continuous Manufacturing Process on Drug Product.
Section II: Design and Control: Continuous Manufacturing of Large Molecule Drug Substances and Products
8. Continuous Manufacturing of Biologics Drug Products: Challenges of Implementing Innovation in cGMP.
9. Modernizing manufacturing of parenteral products: from batch to continuous lyophilization.
Section III: Process Analytical Technologies
10. Near-infrared Spectroscopy as Process Analytical Technology in Continuous Solid Dosage Form Manufacturing.
11. The Role of Process Analytical Technology (PAT) in Biologics Development.
12. Moving to Manufacturing - Lessons Learned in A Career in Process Analytical Technology.
Section IV: Modeling, Design Space, and Future Outlook
13. End-to-end Design Space for Continuous Manufacturing of pharmaceuticals: Understanding interactions across integrated continuous operations.
14. Control strategies in continuous direct compression.
15. Framework for the validation of mechanistic and hybrid models as Process Analytical tools in the pharmaceutical Industry.
16. Understanding the History of Continuous Manufacturing in Other industries to Guide Future Development in Pharmaceuticals.
17. Process Systems Engineering Tools towards Digital Twins of Pharmaceutical Continuous Manufacturing Processes
by "Nielsen BookData"