INDICE: 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-usebioreactors - 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 manufacturers 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 users 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 manufacturers and users 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 asa 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 manufacturing: 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.
- ISBN: 978-0-470-43351-5
- Editorial: John Wiley & Sons
- Encuadernacion: Cartoné
- Páginas: 388
- Fecha Publicación: 23/12/2010
- Nº Volúmenes: 1
- Idioma: Inglés