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Produktbild: Single-Use Technology in Biopharmaceutical Manufacture
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Single-Use Technology in Biopharmaceutical Manufacture

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Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

27.08.2019

Herausgeber

Regine Eibl + weitere

Verlag

John Wiley & Sons Inc

Seitenzahl

368

Maße (L/B/H)

28,4/21,7/2,5 cm

Gewicht

1271 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-1-119-47783-9

Beschreibung

Produktdetails

Einband

Gebundene Ausgabe

Erscheinungsdatum

27.08.2019

Herausgeber

Verlag

John Wiley & Sons Inc

Seitenzahl

368

Maße (L/B/H)

28,4/21,7/2,5 cm

Gewicht

1271 g

Auflage

2nd edition

Sprache

Englisch

ISBN

978-1-119-47783-9

EU-Ansprechpartner

Zeitfracht Medien GmbH
Ferdinand-Jühlke-Straße 7
99095 Erfurt
DE
produktsicherheit@zeitfracht.de

Herstelleradresse

Wiley & Sons
1 Oldlands Way
PO22 9NQ Bognor Regis
GB
trade@wiley.com

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  • Produktbild: Single-Use Technology in Biopharmaceutical Manufacture
  • 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
    &