Continuous manufacturing of pharmaceuticals / edited by Peter Kleinebudde, Johannes Khinast, Jukka Rantanen

"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"--.

"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"--.

1.2.5 Decentralized Manufacturing1.2.6 Individualized Manufacturing; 1.2.7 Reduced Floor Space and Investment Costs; 1.2.8 More Efficient Chemistries; 1.2.9 Societal Benefits; 1.3 Engineering Principles of Continuous Manufacturing; 1.3.1 Pharmaceutical Unit Operations; 1.3.2 Fundamentals of Process Modeling; 1.3.3 Balance Equations for Mass, Species, Energy and Momentum; 1.3.4 Residence Time Distribution; 1.3.5 Classical Reactor Types as a Basis for Process Understanding; 1.3.6 Process Control, Modeling and PAT; 1.3.7 Scale-Up; 1.3.8 Dimensioning; 1.4 Conclusion; References.

2.4 Unit Operations Models2.4.1 Feeders; 2.4.2 Blenders (Mixers); 2.4.3 Tablet Press; 2.4.4 Roller Compactor; 2.4.5 Wet Granulation; 2.4.6 Drying; 2.4.7 Milling/Co-milling; 2.4.8 Flowsheet Modeling; 2.5 Process Control of Continuous Solid-based Drug Manufacturing; 2.5.1 Process Control Basics; 2.5.2 Control Design of Continuous Pharmaceutical Manufacturing Process; 2.6 Summary; Acknowledgments; References; Chapter 3 Regulatory and Quality Considerations for Continuous Manufacturing; 3.1 Introduction; 3.2 Current Regulatory Environment.

3.3 Existing Relevant Regulations, Guidelines, and Standards Supporting Continuous Manufacturing3.3.1 ICH Guidelines; 3.3.2 United States Food and Drug Administration Guidances; 3.3.3 US FDA Guidance on Process Validation; 3.3.4 American Society for Testing and Materials Standards; 3.3.5 European Union Guidelines; 3.4 Regulatory Considerations; 3.4.1 Development Considerations for Continuous Manufacturing; 3.4.2 Special Considerations for Control Strategy in Continuous Manufacturing; 3.4.3 Stability Considerations for Continuous Manufacturing; 3.5 Quality/GMP Considerations.

Cover; Title Page; Copyright; Contents; About the Editors; List of Contributors; Series Preface; Preface; Chapter 1 Continuous Manufacturing: Definitions and Engineering Principles; 1.1 Introduction; 1.1.1 Definition of Continuous Manufacturing; 1.1.2 Continuous Manufacturing in the Pharmaceutical Industry; 1.1.3 Our View of Continuous Manufacturing; 1.1.4 Regulatory Environment; 1.2 Advantages of Continuous Manufacturing; 1.2.1 Flexibility; 1.2.2 Effect on the Supply Chain; 1.2.3 Agility and Reduced Scale-up Efforts; 1.2.4 Real-Time Quality Assurance and Better Engineered Systems.

Chapter 2 Process Simulation and Control for Continuous Pharmaceutical Manufacturing of Solid Drug Products2.1 Introduction; 2.1.1 Scope and Motivation; 2.1.2 Process Simulation; 2.1.3 Process Control; 2.2 Pharmaceutical Solid Dosage Manufacturing Processes; 2.2.1 Overview; 2.2.2 Continuous Manufacturing Processes; 2.2.3 Continuous Process Equipment; 2.3 Mathematical Modeling Approaches; 2.3.1 First Principle ""Mechanistic"" Models; 2.3.2 Multi-dimensional Population Balance Models; 2.3.3 Engineering or Phenomenological Models; 2.3.4 Empirical and Reduced Order Models.

Medienart:	E-Book

Erscheinungsjahr:	2017
Erschienen:	Hoboken, NJ: John Wiley & Sons Ltd ; 2017

Reihe:	Advances in pharmaceutical technology

Sprache:	Englisch

Beteiligte Personen:	Khinast, Johannes, 1964- [HerausgeberIn] Rantanen, Jukka [HerausgeberIn] Kleinebudde, Peter, 1958- [HerausgeberIn]

Links:	Volltext onlinelibrary.wiley.com

ISBN:	1-119-00133-1 1-119-00135-8 1-119-00134-X 978-1-119-00133-1 978-1-119-00135-5 978-1-119-00134-8

BKL:	58.28 / Pharmazeutische Technologie
Themen:	Drug Compounding MEDICAL ; Pharmacology Pharmaceutical industry Pharmaceutical technology SCIENCE ; Chemistry ; Industrial & Technical Technology, Pharmaceutical

Anmerkungen:	Includes bibliographical references and index

Umfang:	1 Online-Ressource (xxviii, 599 pages)

doi:	10.1002/9781119001348

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	1014965918