Continuous Biomanufacturing - Ganapathy Subramanian

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Résumé :
This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.

Biographie:
Dr. Ganapathy Subramanian is a biotechnology consultant with over 30 years of experience in industry and academia, encompassing the application and development of processing, purification methodologies, and chromatographic systems for large scale use in environmental science, food science, perfumery, cosmetics, and pharmaceuticals. He has also taught extensively in the area of food and medical technology.
A chemistry graduate from Madras, India, Dr. Subramanian was awarded his doctorate from the University of Glasgow for work on natural products. His main research interests lie in the utilization of natural material separation processes and bioconversions.
Dr. Subramanian has written and edited a number of books and articles in the field of biotechnology. For the last 15 years, he has been organizing conferences promoting the integration and sharing of knowledge between academia and industry.

Sommaire:
1. Continuous Bioprocess Development: Methods for Control and Characterization of the Biological System 2. Tools Enabling Continuous and Integrated Upstream and Downstream Processes in the Manufacturing of Biologicals 3. Engineering Challenges of Continuous Biomanufacturing Processes (CBP) 4. Progress Towards Automated Single Use Continuous Monoclonal Antibody Manufacturing via the Protein Refinery Operations Lab 5. Single-use bioreactors for continuous bioprocessing: challenges and outlook 6. Two mutually enabling trends: Continuous bioprocessing and Single-use technologies 7. Perfusion Formats and their specific medium requirements 8. Upstream Continuous Process Development 9. Study of Cells in the Steady State Growth Space 10. Continuous Downstream Processing for Production of Biotech Therapeutics 11. Evolving Needs For Viral Safety Strategies in Continuous Monoclonal Antibody Bioproduction 12. Multi-Column Continuous Chromatography ? Understanding this enabling Technology 13. Continuous Chromatography as a fully integrated process in Continuous Biomanufacturing 14. Continuous Chromatography in Biomanufacturing 15. Single Pass Tangential Flow Filtration (SPTFF) in Continuous Biomanufacturing 16. Design of Integrated Continuous Processes for high quality Biotherapeutics 17. Integration of upstream and downstream in continuous biomanufacturing 18. Quality control and regulatory aspects for continuous biomanufacturing 19. Continious Validation for Continous Processing 20. Validation, uality and Regulatory Considerations in Continuous Biomanufacturing 21. Evaluation of Continuous Downstream processing: Industrial Perspective