Single-use technology in biopharmaceutical manufacture

"This book gives an overview of commonly-used disposables in the manufacture of biopharmaceuticals, their working principles, characteristics, engineering aspects, economics, and applications. With this information, readers will be able to come to an easier decision for or against disposable alternatives and to choose the appropriate system. The book is divided into two parts -- the first is related to basic knowledge about disposable equipment; and the second discusses applications through case studies that illustrate manufacturing, quality assurance, and environmental influence. This revision updates existing information with developments that have taken place since the prior edition as well as presents the latest developments in the field of single-use technology. For example, there is considerable interest in applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells"--Provided by publisher.

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; Sö 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 Ty…