Single-Use Technology in Biopharmaceutical Manufacture
2nd Edition
Will be published approx. on 1. August 2019
Book
Hardback
400 pages
978-1-119-47783-9 (ISBN)
Description
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.
More details
Other editions
Additional editions
Regine Eibl | Dieter Eibl
Single-Use Technology in Biopharmaceutical Manufacture
E-Book
07/2019
2nd Edition
Wiley
€163.99
Available for download
Regine Eibl | Dieter Eibl
Single-Use Technology in Biopharmaceutical Manufacture
E-Book
07/2019
2nd Edition
Wiley
€163.99
Available for download
Previous edition
Regine Eibl | Dieter Eibl
Single-Use Technology in Biopharmaceutical Manufacture
Book
01/2011
Wiley
Unfortunately, price unknown
Article exhausted; check for reprint
Persons
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.
Content
List of Contributors
Preface
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