Continuous Pharmaceutical Processing and Process Analytical Technology (Hardcover, 1)

Section I: Design and Control: Continuous Manufacturing of Small Molecule Drug Substances and Products 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*,a, Yiming Ma a, Junbo Gong a; a School of Chemical Engineering and Technology, State Key Laboratory of Chemical Engineering, Tianjin University, Tianjin 300072, People’s Republic of China Residence Time Distribution in Continuous Manufacturing. Sonia M. Razavi, Atul Dubey, Fernando J. Muzzio Powder Electrostatics in Continuous Pharmaceutical Manufacturing. Michela Berettaa,b, Joana T. Pintoa, Amrit Paudela,b; a Research Center Pharmaceutical Engineering GmbH, Graz, 8010, Austria; b Institute of Process and Particle Engineering, Graz University of Technology, Graz, 8010, Austria 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; Pharmaceutical R&D, F. Hoffmann-La Roche AG, Grenzacherstrasse 124, 4070 Basel, Switzerland Predictive In-Vitro Dissolution for Real-time Release Test (RTRT) for Continuous Manufacturing Process on Drug Product. Zhenqi Shi1, Stan Altan2, Dwaine Banton2, Sarah Nielsen3, Martin Otava4, Aaron Garrett5 and Matthew Wallworth6; 1. Small molecule pharmaceutical Sciences, Genentech, South San Francisco, CA; 2. Janssen Pharmaceutical LLC., Spring house, PA; 3. Janssen Supply Chain, Spring house, PA; 4. Janssen-Cilag s.r.o.. Janssen Pharmaceutical Companies of Johnson & Johnson, Walterovo nam?sti 329, Praha, Czechia; 5. Global quality laboratory, Eli Lilly and Company, Indianapolis, IN; 6. Small molecule design and development, Eli Lilly and Company, Indianapolis, IN Section II: Design and Control: Continuous Manufacturing of Large Molecule Drug Substances and Products Continuous Manufacturing of Biologics Drug Products: Challenges of Implementing Innovation in cGMP. Erinc Sahin*1, James Angelo2, Jay West2, Xuankuo Xu2, Global Product Development & Supply, Bristol Myers Squibb, 1-New Brunswick, NJ, USA; 2-Devens, MA, USA Modernizing manufacturing of parenteral products: from batch to continuous lyophilization. Roberto Pisano, Merve B. Adali, and Lorenzo Stratta, Molecular Engineering Laboratory (molE), Department of Applied Science and Technology, Politecnico di Torino, 24 corso Duca degli Abruzzi, IT-10129 Torino, Italy Section III: Process Analytical Technologies Near-infrared Spectroscopy as Process Analytical Technology in Continuous Solid Dosage Form Manufacturing. Michiel Peeters1,*, Prof. Dr. Thomas De Beer1, Prof. Dr. Ashish Kumar2, 1Laboratory of Pharmaceutical Process Analytical Technology, Department of Pharmaceutical Analysis, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium; 2Laboratory of Pharmaceutical Engineering, Ghent University, Ottergemsesteenweg 460, 9000 Ghent, Belgium The Role of Process Analytical Technology (PAT) in Biologics Development. Dhanuka P. Wasalathanthri, Ph.D. ￥ * & Bhumit A. Patel, Ph.D.?; ￥ Global Process Development Analytics, Bristol-Myers Squibb Company, 38 Jackson Road, Devens, Massachusetts 01434, United States; ?Analytical Research and Development, Merck & Co., Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, United States. Moving to Manufacturing ? Lessons Learned in A Career in Process Analytical Technology. Rodolfo J Romanach, Ph.D., Department of Chemistry, University of Puerto Rico, Mayaguez Campus, Mayaguez, Puerto Rico 00681 Section IV: Modeling, Design Space, and Future Outlook End-to-end Design Space for Continuous Manufacturing of pharmaceuticals: Understanding interactions across integrated continuous operations. Sayantan Chattoraj, Ph.D., Pharmaceutical Development, GlaxoSmithKline Pharmaceuticals R&D, Collegeville, PA, USA Control strategies in continuous direct compression. Aditya Vanarase, Sherif Badawy; Bristol Myers Squibb Company, 1 Squibb Drive, New Brunswick, NJ-08901 Framework for the validation of mechanistic and hybrid models as Process Analytical tools in the pharmaceutical Industry. Pedro Valente, Hovione FarmaCiencia, Lisbon, Portugal; Luis Eca, Instituto Superior Tecnico, Lisbon, Portugal; Nuno Matos, Hovione FarmaCiencia, Lisbon, Portugal Understanding the History of Continuous Manufacturing in Other industries to Guide Future Development in Pharmaceuticals. Ian M. Leavesley, President, Modern Pharma Consulting LLC