Single-Use Technology in Biopharmaceutical Manufacture (eBook, ePUB)

Redaktion: Eibl, Regine; Eibl, Dieter

• Format: ePub

Produktbeschreibung

Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors--noted experts on the topic--provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals' applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: * Contains an updated and end-to-end view of the development and manufacturing of single-use biologics * Helps in the identification of appropriate disposables and relevant vendors * Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences * Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 368
• Erscheinungstermin: 24. Juli 2019
• Englisch
• ISBN-13: 9781119477778
• Artikelnr.: 57497792

Autorenporträt

REGINE EIBL, PHD, is a professor at the Zurich University of Applied Sciences (Switzerland), where she lectures in biotechnology and cell cultivation techniques. DIETER EIBL, PHD, is a professor at the Zurich University of Applied Sciences, where he lectures in biochemical engineering and the planning of biotechnological production facilities.

Inhaltsangabe

List of Contributors xvii

Preface xxi

Part I Basics 1

1 Single-Use Equipment in Biopharmaceutical Manufacture: A Brief Introduction 3
Dieter Eibl and Regine Eibl

1.1 Background 3

1.2 Terminology and Features 3

1.3 Single-Use Systems in Production Processes for Therapeutic Proteins such as mAbs: Product Overview and Classification 5

1.4 Single-Use Production Facilities 7

1.5 Summary and Conclusions 7

Nomenclature 9

References 9

2 Types of Single-Use Bag Systems and Integrity Testing Methods 13
Jens Rumsfeld and Regine Eibl

2.1 Introduction 13

2.2 Bags for Fluid and Powder Handling 13

2.3 Bag-Handling and Container Systems 15

2.4 Single-Use Bag Systems for Freezing and Thawing 18

2.5 Container Closure Integrity Testing 18

2.6 Summary and Conclusions 22

Nomenclature 22

References 22

3 Mixing Systems for Single-Use 25
Sören Werner, Matthias Kraume, and Dieter Eibl

3.1 Introduction 25

3.2 The Mixing Process 25

3.3 Single-Use Bag Mixing Systems 27

3.4 Summary and Conclusions 33

Nomenclature 33

References 33

4 Single-Use Bioreactors - An Overview 37
Valentin Jossen, Regine Eibl, and Dieter Eibl

4.1 Introduction 37

4.2 SUB History 38

4.3 Comparison of the Current, Most Common SUB Types 40

4.4 Decision Criteria for Selection of the Most Suitable SUB Type 47

4.5 Summary and Future Trends 48

Nomenclature 48

References 48

5 Systems for Coupling and Sampling 53
Cedric Schirmer, Sebastian Rothe, Ernest Jenness, and Dieter Eibl

5.1 Introduction 53

5.2 Components of Single-Use Transfer Lines 53

5.3 Systems for Aseptic Coupling 57

5.4 Aseptic Disconnection 62

5.5 Systems for Sampling 64

5.6 Summary and Conclusion 66

Nomenclature 66

References 66

6 Sensors for Disposable Bioreactor Systems 69
Tobias Steinwedel, Katharina Dahlmann, Dörte Solle, Thomas Scheper, Kenneth F. Reardon, and Frank Lammers

6.1 Introduction 69

6.2 Interfaces for Sensor Technology 70

6.3 Considerations of Extractables and Leachables from Integrated Sensors 71

6.4 Optical Chemosensors 72

6.5 Spectroscopic Sensors 73

6.6 Capacitance Sensors 75

6.7 Electrochemical Sensors 76

6.8 Biosensors 78

6.9 Conclusions and Outlook 78

Nomenclature 79

References 79

7 Bioinformatics and Single-Use 83
Barbara A. Paldus

7.1 Introduction 83

7.2 Bioinformatics and Single-Use 84

7.3 Smart Sensors 86

7.4 Intelligent Control Systems 87

7.5 Continuous Processing 88

7.6 Conclusions 92

Nomenclature 94

References 94

8 Production of Disposable Bags: A Manufacturer's Report 95
Steven Vanhamel and Catherine Piton

8.1 Introduction 95

8.2 Materials 95

8.4 Bag Manufacturing 110

8.5 Summary and Conclusions 113

Nomenclature 115

References 116

9 Single-Use Downstream Processing for Biopharmaceuticals: Current State and Trends 117
Britta Manser, Martin Glenz, and Marc Bisschops

9.1 Introduction 117

9.2 Single-Use DSP Today 117

9.3 Technologies in Single-Use DSP 120

9.4 Single-Use Continuous Downstream Processing 121

9.5 Integrated and Continuous DSP 124

9.6 Summary and Conclusions 124
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