Continuous Manufacturing of Pharmaceuticals

Herausgegeben:Kleinebudde, Peter; Khinast, Johannes; Rantanen, Jukka

• Gebundenes Buch

Produktbeschreibung

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.

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Produktdetails

• Advances in Pharmaceutical Technology
• Verlag: Wiley / Wiley & Sons
• Artikelnr. des Verlages: 1W119001320
• 1. Auflage
• Seitenzahl: 640
• Erscheinungstermin: 28. Oktober 2024
• Englisch
• Abmessung: 251mm x 174mm x 38mm
• Gewicht: 1092g
• ISBN-13: 9781119001324
• ISBN-10: 1119001323
• Artikelnr.: 48686714

Autorenporträt

Editors 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.

Inhaltsangabe

About the Editors xvii

List of Contributors xix

Series Preface xxv

Preface xxvii

1 Continuous Manufacturing: Definitions and Engineering Principles 1
Johannes Khinast and Massimo Bresciani

1.1 Introduction 1

1.1.1 Definition of Continuous Manufacturing 1

1.1.2 Continuous Manufacturing in the Pharmaceutical Industry 2

1.1.3 Our View of Continuous Manufacturing 3

1.1.4 Regulatory Environment 8

1.2 Advantages of Continuous Manufacturing 8

1.2.1 Flexibility 8

1.2.2 Effect on the Supply Chain 8

1.2.3 Agility and Reduced Scale-up Efforts 9

1.2.4 Real-Time Quality Assurance and Better Engineered Systems 9

1.2.5 Decentralized Manufacturing 10

1.2.6 Individualized Manufacturing 10

1.2.7 Reduced Floor Space and Investment Costs 10

1.2.8 More Efficient Chemistries 10

1.2.9 Societal Benefits 11

1.3 Engineering Principles of Continuous Manufacturing 11

1.3.1 Pharmaceutical Unit Operations 11

1.3.2 Fundamentals of Process Modeling 15

1.3.3 Balance Equations for Mass, Species, Energy and Momentum 16

1.3.4 Residence Time Distribution 20

1.3.5 Classical Reactor Types as a Basis for Process Understanding 21

1.3.6 Process Control, Modeling and PAT 24

1.3.7 Scale-Up 26

1.3.8 Dimensioning 27

1.4 Conclusion 28

References 30

2 Process Simulation and Control for Continuous Pharmaceutical Manufacturing of Solid Drug Products 33
Marianthi Ierapetritou, M. Sebastian Escotet-Espinoza and Ravendra Singh

2.1 Introduction 33

2.1.1 Scope and Motivation 33

2.1.2 Process Simulation 34

2.1.3 Process Control 36

2.2 Pharmaceutical Solid Dosage Manufacturing Processes 38

2.2.1 Overview 38

2.2.2 Continuous Manufacturing Processes 38

2.2.3 Continuous Process Equipment 39

2.3 Mathematical Modeling Approaches 44

2.3.1 First Principle "Mechanistic" Models 44

2.3.2 Multi-dimensional Population Balance Models 44

2.3.3 Engineering or Phenomenological Models 46

2.3.4 Empirical and Reduced Order Models 47

2.4 Unit Operations Models 48

2.4.1 Feeders 48

2.4.2 Blenders (Mixers) 56

2.4.3 Tablet Press 63

2.4.4 Roller Compactor 67

2.4.5 Wet Granulation 71

2.4.6 Drying 75

2.4.7 Milling/Co-milling 76

2.4.8 Flowsheet Modeling 77

2.5 Process Control of Continuous Solid-based Drug Manufacturing 81

2.5.1 Process Control Basics 83

2.5.2 Control Design of Continuous Pharmaceutical Manufacturing Process 84

2.6 Summary 93

Acknowledgments 94

References 94

3 Regulatory and Quality Considerations for Continuous Manufacturing 107
Gretchen Allison, Yanxi Tan Cain, Charles Cooney, Tom Garcia, Tara GooenBizjak, Oyvind Holte, Nirdosh Jagota, Bekki Komas, Evdokia Korakianiti,Dora Kourti, Rapti Madurawe, Elaine Morefield, Frank Montgomery, MohebNasr, William Randolph, Jean-Louis Robert, Dave Rudd and Diane Zezza

3.1 Introduction 108

3.2 Current Regulatory Environment 108

3.3 Existing Relevant Regulations, Guidelines, and Standards Supporting Continuous Manufacturing 108

3.3.1 ICH Guidelines 108

3.3.2 United States Food and Drug Administration Guidances 109

3.3.3 US FDA Guidance on Process Validation 109

3.3.4 American Society for Testing and Materials Standards 109

3.3.5 European Union Guidelines 110

3.4 Regula