Single–Use Technology in Biopharmaceutical Manufacture

An introduction and comprehensive reference to disposables in biomanufacturing
Increasingly, single–use devices (also called disposables) have been replacing their reusable stainless steel counterparts in modern biopharmaceutical processes. Single–use systems offer increased flexibility and versatility while mitigating the risk of contamination during biomanufacturing. The potential reduction in energy, labor, and cleaning costs, along with elimination of cleaning solution wastes and their disposal, offers significant economic advantages. This book provides a practical overview of commonly used disposables in the manufacture of biopharmaceuticals, as well as their working principles, characteristics, engineering aspects, economics, and applications.
Serving as both an introduction and practical reference to this growing area in biopharmaceutical manufacturing, Single–Use Technology in Biopharmaceutical Manufacture:
Helps readers identify appropriate disposables (and relevant vendors) for their processes
Offers an overview of the main single–use devices for biomanufacturing, and describes their implementation
Illustrates manufacturing, quality assurance, and environmental influence with clear case studies
Part I of the book introduces the user to single–use equipment in biopharmaceutical manufacture, while Part II represents a case study collection.
With the information in this thorough and up–to–date resource, biopharmaceutical professionals, engineers, and researchers will be better prepared for making effective decisions regarding disposable alternatives and appropriate systems for their applications.

Spis treści:
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 – an overview.
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 application.
10. Production of disposable Bags: A manufacturer’s report.
11. Disposable filter devices.
12. Biopharmaceutical manufacturing facilities integrating single–use systems.
13. An introduction to the validation and qualification of disposables used in biomanufacture – a user’s perspective.
14. Waste generation, treatment options and the environmental impact of single use systems.
15. Next generation single–use bioreactor technology and the future of biomanufacturing: A summary from manufacturer’s and user’s perspective Single–Use Technology in Biopharmaceutical Manufacture.
Part II: Application reports and case studies.
1. Disposable SuperSpinner: Characteristics and typical applications.
2. A new scale–down approach for the rapid development of Sf21/BEVS–based processes – a case study.
3. Practical aspects of establishing pharmaceutical recombinant proteins from research to development in disposable bioreactors.
4. Single–use stirred tank reactor BIOSTAT CultiBag STR: Characterization and applications.
5. Single–use bioreactor platform for microbial fermentation.
6. Growth of BY–2 suspension cells and plantibody production in single–use bioreactors.
7. CFD as a tool to characterize single–use bioreactors.
8. Automated disposable systems: Application reports.
9 New single–use sensors for online measurement of glucose and lactate, the answer to the PAT Initiative.
10. Disposable Chromatography for large–scale biomanufacturing.
11. Single–use virus clearance technologies in biopharmaceutical manufactur ing: Case studies.
12. A single–use technology platform for downstream processing: Mobius FlexReady Solutions.
13. The manufacture of MAbs – a comparison of performance and process time between traditional and ready–to–use, disposable systems.
14. Going fully disposable – current possibilities: A case study from Crucell.
15. Production Costs in Biotech Facilities: Single Use vs. Multiple Use Equipment for Antibody Manufacture.

Nota biograficzna:
Regine Eibl is a professor at the Zurich University of Applied Sciences (Switzerland), where she lectures in biotechnology and cell cultivation techniques.
Dieter Eibl is a professor at the Zurich University of Applied Sciences, where he lectures in biochemical engineering and the planning of biotechnological production facilities.

Okładka tylna:
An introduction and comprehensive reference to disposables in biomanufacturing
Increasingly, single–use devices (also called disposables) have been replacing their reusable stainless steel counterparts in modern biopharmaceutical processes. Single–use systems offer increased flexibility and versatility while mitigating the risk of contamination during biomanufacturing. The potential reduction in energy, labor, and cleaning costs, along with elimination of cleaning solution wastes and their disposal, offers significant economic advantages. This book provides a practical overview of commonly used disposables in the manufacture of biopharmaceuticals, as well as their working principles, characteristics, engineering aspects, economics, and applications.
Serving as both an introduction and practical reference to this growing area in biopharmaceutical manufacturing, Single–Use Technology in Biopharmaceutical Manufacture:
Helps readers identify appropriate disposables (and relevant vendors) for their processes
Offers an overview of the main sin gle–use devices for biomanufacturing, and describes their implementation
Illustrates manufacturing, quality assurance, and environmental influence with clear case studies
Part I of the book introduces the user to single–use equipment in biopharmaceutical manufacture, while Part II represents a case study collection.
With the information in this thorough and up–to–date resource, biopharmaceutical professionals, engineers, and researchers will be better prepared for making effective decisions regarding disposable alternatives and appropriate systems for their applications.