Single-Use Technology in Biopharmaceutical Manufacture

Informationen zum Autor 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. Klappentext Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticalsThe 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 technologiesWritten 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. Zusammenfassung Authoritative guide to the principles! characteristics! engineering aspects! economics! and applications of disposables in the manufacture of biopharmaceuticalsThe 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 depen...

Auteur

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.

Texte du rabat

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.

Contenu

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
*S*ö*ren 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 L…