1 Continuous Manufacturing: Definitions and Engineering Principles 1
2 Process Simulation and Control for Continuous Pharmaceutical Manufacturing of Solid Drug Products 33
3 Regulatory and Quality Considerations for Continuous Manufacturing 107
4 Continuous Manufacturing of Active Pharmaceutical Ingredients via Flow Technology 127
5 Continuous Crystallisation 169
6 Continuous Fermentation for Biopharmaceuticals? 227
7 Integrated Continuous Manufacturing of Biopharmaceuticals 247
8 Twin-screw Granulation Process Development: Present Approaches, Understanding and Needs 283
9 Continuous Line Roller Compaction 313
10 Continuous Melt Extrusion and Direct Pelletization 337
11 Continuous Processing in the Pharmaceutical Industry: Status and Perspective 369
12 Design of an Integrated Continuous Manufacturing System 405
13 End to End Continuous Manufacturing: Integration of Unit Operations 447
14 Methodology for Economic and Technical Comparison of Continuous and Batch Processes to Enhance Early Stage Decision-making 485
15 Drivers for a Change – Manufacturing of Future Medicines for Personalized Drug Therapies 507
16 Perspectives of Printing Technologies in Continuous Drug Manufacturing 525
17 Development of Liquid Dispensing Technology for the Manufacture of Low Dose Drug Products 551
A comprehensive look at existing technologies and processes for continuous manufacturing of pharmaceuticals
As rising costs outpace new drug development, the pharmaceutical industry has come under intense pressure to improve the efficiency of its manufacturing processes. Continuous process manufacturing provides a proven solution. Among its many benefits are: minimized waste, energy consumption, and raw material use; the accelerated introduction of new drugs; the use of smaller production facilities with lower building and capital costs; the ability to monitor drug quality on a continuous basis; and enhanced process reliability and flexibility. Continuous Manufacturing of Pharmaceuticals prepares professionals to take advantage of that exciting new approach to improving drug manufacturing efficiency.
This book covers key aspects of the continuous manufacturing of pharmaceuticals. The first part provides an overview of key chemical engineering principles and the current regulatory environment. The second covers existing technologies for manufacturing both small-molecule-based products and protein/peptide products. The following section is devoted to process analytical tools for continuously operating manufacturing environments. The final two sections treat the integration of several individual parts of processing into fully operating continuous process systems and summarize state-of-art approaches for innovative new manufacturing principles.
• Brings together the essential know-how for anyone working in drug manufacturing, as well as chemical, food, and pharmaceutical scientists working on continuous processing
• Covers chemical engineering principles, regulatory aspects, primary and secondary manufacturing, process analytical technology and quality-by-design
• Contains contributions from researchers in leading pharmaceutical companies, the FDA, and academic institutions
• Offers an extremely well-informed look at the most promising future approaches to continuous manufacturing of innovative pharmaceutical products
Timely, comprehensive, and authoritative, Continuous Manufacturing of Pharmaceuticals is an important professional resource for researchers in industry and academe working in the fields of pharmaceuticals development and manufacturing.
• Peter Kleinebudde is Professor for Pharmaceutical Technology at Heinrich-Heine-University Duesseldorf, Germany, and Vice-Dean of the Faculty of Mathematics and Natural Sciences. His main research area is development, production and characterization of solid dosage forms.
• Johannes Khinast is Professor of Chemical and Pharmaceutical Engineering and Head of the Institute of Process and Particle Engineering at the Graz University of Technology, Austria.
• Jukka Rantanen is Professor of Pharmaceutical Technology and Engineering at the Department of Pharmacy, University of Copenhagen, Denmark.