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Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition





Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition

Regine Eibl, Dieter Eibl

ISBN: 978-1-119-47783-9 August 2019 400 Pages

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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.

List of Contributors


Chapter 1. Single-Use Equipment in Biopharmaceutical Manufacture: A Brief Introduction

Chapter 2. Types of Single-Use Bag Systems and Integrity Testing Methods

Chapter 3. Mixing Systems for Single-Use

Chapter 4. Single-Use Bioreactors – An Overview

Chapter 5. Systems for Coupling and Sampling

Chapter 6. Sensors for Disposable Bioreactor Systems

Chapter 7. Bio-informatics and Single-Use

Chapter 8. Production of Disposable Bags: A Manufacturer`s Report

Chapter 9. Single-Use Downstream Processing for Biopharmaceuticals: Current State and Trends

Chapter 10. Application of Microporous Filtration in Single-Use Systems

Chapter 11. Extractables/Leachables from Single-Use Equipment: Considerations from a (Bio)pharmaceutical Manufacturer

Chapter 12. The Single-Use Standardization

Chapter 13. Environmental Impacts of Single-Use Systems

Chapter 14. Design Considerations Towards an Intensified Single-Use Facility

Chapter 15. Single-Use Technologies in Biopharmaceutical Manufacturing: A 10-year Review of Trends and the Future

Chapter 16. Single-Use Process Platforms for Responsive & Cost-Effective Manufacturing

Chapter 17. Considerations on Performing Quality Risk Analysis for Production Processes with Single-Use Systems

Chapter 18. How to Assure Robustness, Sterility and Performance of Single-Use Systems: A Quality Approach from the Manufacturer`s Perspective

Chapter 19. How to Design and Qualify an Improved Film for Storage and Bioreactor Bags

Chapter 20. An Approach for Rapid Manufacture and Qualification of a Single-Use Bioreactor Prototype

Chapter 21. Single-Use Bioreactor Platform for Microbial Fermentation

Chapter 22. Engineering Parameters in Single-Use Bioreactors: Flow, Mixing, Aeration and Suspension.

Chapter 23. Title: Alluvial Filtration an Effective and Economical Solution for Midstream Application (e.g. Cell and Host Cell Proteins Removal)

Chapter 24. Single-Use Continuous Downstream Processing for Biopharmaceutical Products

Chapter 25. Single-Use Technology for Formulation and Filling Applications

Chapter 26. Facility Design Considerations for Mammalian Cell Culture

Chapter 27. Progress in the Development of Single-Use Solutions in Antibody-Drug Conjugate (ADC) Manufacturing

Chapter 28. Single-Use Processing as a Safe and Convenient Way to Develop and Manufacture Moss-Derived Biopharmaceuticals

Chapter 29. Single-Use Technologies Used in Cell & Gene Therapy Manufacturing Need to Fulfill Higher and Novel Requirements: How Can this Challenge be Addressed?

Chapter 30. Single-Use Bioreactors for Manufacturing of Immune Cell Therapeutics