Single-Use Biopharmaceutical (Hardcover)

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 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.