Continuous pharmaceutical processing and process analytical technology / edited by Ajit S. Narang, Atul Dubey
"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. 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"--.
| Medienart: |
Buch |
|---|
| Erscheinungsjahr: |
2023 |
|---|---|
| Erschienen: |
Boca Raton London New York: CRC Press ; 2023 |
| Ausgabe: |
First edition |
| Reihe: |
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| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Narang, Ajit S. [HerausgeberIn] |
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| Links: |
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| ISBN: |
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| Nlm: |
QV 778 |
|---|---|
| BKL: | |
| Themen: |
Chemistry, Pharmaceutical |
| Anmerkungen: |
Literaturangaben |
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| Umfang: |
xv, 478 Seiten ; Illustrationen, Diagramme |
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| Förderinstitution / Projekttitel: |
|
|---|
| PPN (Katalog-ID): |
1818433737 |
|---|
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| 250 | |a First edition | ||
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| 500 | |a Literaturangaben | ||
| 505 | 8 | 0 | |a A Survey of Continuous API Syntheses : Insights at the Interface of Chemistry and Chemical Engineering /John W. Tomlin, Dylan D. Rodene, B. Frank Gupton -- Development of Continuous Pharmaceutical Crystallization / Wu Songgu, Yiming Ma, Junbo Gong -- Residence Time Distribution in Continuous Manufacturing / Sonia M. Razavi, Atul Dubey, Fernando J. Muzzio -- Powder Electrostatics in Continuous Pharmaceutical Manufacturing / Michela Beretta, Joana T. Pinto, Amrit Paudel -- Continuous Impregnation Processes / Thamer Omar and Fernando Muzzio -- Leveraging a mini-batch wise continuous direct compression (CDC) approach to optimize efficiency in process development, on-demand manufacturing and continuous process verification (CPV) / Martin Warman, Patrick M. Piccione, Reto Maurer -- Predictive In-Vitro Dissolution for Real-time Release Test (RTRT) for Continuous Manufacturing Process on Drug Product / Zhenqi Shi, Stan Altan, Dwaine Banton, Sarah Nielsen, Martin Otava, Aaron Garrett and Matthew Wallworth -- Continuous Manufacturing of Biologics Drug Products : Challenges of Implementing Innovation in cGMP / Erinc Sahin, James Angelo, Jay West, Xuankuo Xu -- Modernizing manufacturing of parenteral products: from batch to continuous lyophilization / Roberto Pisano, Merve B. Adali, and Lorenzo Stratta -- Near-infrared Spectroscopy as Process Analytical Technology in Continuous Solid Dosage Form Manufacturing / Michiel Peeters, Prof. Dr. Thomas De Beer, Prof. Dr. Ashish Kumar -- The Role of Process Analytical Technology (PAT) in Biologics Development / Dhanuka P. Wasalathanthri, Ph.D. & Bhumit A. Patel, Ph.D -- Moving to Manufacturing : Lessons Learned in A Career in Process Analytical Technology / Rodolfo J Romañach, Ph.D -- End-to-end Design Space for Continuous Manufacturing of pharmaceuticals : Understanding interactions across integrated continuous operations / Sayantan Chattoraj, Ph.D -- Control strategies in continuous direct compression / Aditya Vanarase & Sherif Badawy -- Framework for the validation of mechanistic and hybrid models as Process Analytical tools in the pharmaceutical Industry / Pedro Valente, Luís Eça, Nuno Matos -- Understanding the History of Continuous Manufacturing in Other industries to Guide Future Development in Pharmaceuticals / Ian M. Leavesley. |
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