Single-Use Technology in Biopharmaceutical Manufacture
edited by Regine Eibl

Single-Use Technology in Biopharmaceutical Manufacture covers commonly-used disposables in the manufacture of biopharmaceuticals, their working principles, characteristics, engineering aspects, economics, and applications.

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.

Contents

Part I: Basics

1. Single-use equipment in biopharmaceutical manufacture: A brief introduction
2. Single-use bag systems for storage, transportation, freezing and thawing
3. Bag mixing systems for single-use
4. Single-use bioreactors
5. Systems for coupling and sampling
6. Disposable sensor systems
7. Bio-informatics and single-use
8. Single-use downstream equipment
9. Single-use technology for formulation and filling applicationvProduction of disposable Bags: A manufacturer’s report
10. Disposable filter devices
11. Biopharmaceutical manufacturing facilities integrating single-use systems
12. An introduction to the validation and qualification of disposables used in biomanufacture - a user’s perspective
13. Waste generation, treatment options and the environmental impact of single use systems
14. Next generation single-use bioreactor technology and the future of biomanufacturing: A summary from manufacturer’s and user’s perspective
15. Single-Use Technology in Biopharmaceutical Manufacture

Part II: Application reports and case studies

16. Disposable SuperSpinner: Characteristics and typical applications
17. A new scale-down approach for the rapid development of Sf21/BEVS-based processes - a case study
18. Practical aspects of establishing pharmaceutical recombinant proteins from research to development in disposable bioreactors
19. Single-use stirred tank reactor BIOSTAT CultiBag STR: Characterization and applications
20. Single-use bioreactor platform for microbial fermentation
21. Growth of BY-2 suspension cells and plantibody production in single-use bioreactors
22. CFD as a tool to characterize single-use bioreactors
23. Automated disposable systems: Application reports
24. New single-use sensors for online measurement of glucose and lactate, the answer to the PAT Initiative
25. Disposable Chromatography for large-scale biomanufacturing
26. Single-use virus clearance technologies in biopharmaceutical manufacturing: Case studies
27. A single-use technology platform for downstream processing: Mobius FlexReady Solutions
28. The manufacture of MAbs - a comparison of performance and process time between traditional and ready-to-use, disposable systems
29. Going fully disposable - current possibilities: A case study from CrucellvProduction Costs in Biotech Facilities: Single Use vs. Multiple Use Equipment for Antibody Manufacture

Index

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