Continuous manufacturing of pharmaceuticals, including aspects of modern process development is highlighted in this book with both the 'why' and the 'how', emphasizing process modeling and process analytical technologies. Presenting specific case studies and drawing upon extensive experience from industry and academic opinion leaders, this book focuses on the practical aspects of continuous manufacturing. It gives the readers the strategic perspective and technical depth needed to adopt and implement these technologies, where appropriate, in order to gain the competitive edge in speed, agility, and reliability.
Features:
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
Inhaltsverzeichnis
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
