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JOSEPH BERTOLINI, BSc (HONS.), MSc, PhD, is R&D Manager at CSL Bioplasma where he has been closely involved in the technical development and improvement of immunoglobulin and albumin products. He is active in national and international conferences and industry organizations and is a strong advocate for the advancement of bioprocessing.
NEIL GOSS, BSc (HONS.), PhD, is Executive Director at Further Options Pty Ltd., a consulting company specializing in biotechnology and the plasma fractionation industry. He was previously Director of R&D, CSL Bioplasma and is the founding organizer for both the Plasma Product Biotechnology Meeting series and the BioProcessing Network.
JOHN CURLING, BSc, is a consultant in bioseparations and protein purification whose clients have included numerous biopharmaceutical, biotechnology, and vendor companies. He pioneered the development of chromatographic methods of plasma fractionation and was the President of the Process Separation Division of Pharmacia. He has acted as an advisor to the World Health Organization.
1. Introduction to plasma fractionation
Chapter 1. The history and development of the plasma protein fractionation industry
John Curling, Neil Goss and Joseph Bertolini
2. Plasma proteins for therapeutic use
Chapter 2. Production and clinical profile of human plasma coagulation Factor VIII
Sami Chtourou
Chapter 3. Human plasma-derived von Willebrand Factor
Sami Chtourou and Michel Poulle
Chapter 4. Factor VIII inhibitor by-pass activity (FEIBA)
Peter Turecek and Hans Peter Schwartz
Chapter 5. Prothrombin Complex
Jürgen Römisch and Katharina Pock
Chapter 6. Factor IX
Salvador Grancha, Steven Herring, Antonio Páez, Pere Ristol and Juan Ignacio Jorquera
Chapter 7. Factor XI
Sami Chtourou and Michel Poulle
Chapter 8. Factor XIII and Factor X
Peter Feldman
Chapter 9. Fibrinogen: science and biotechnology
Gerard Marx
Chapter 10. Fibrin glues and bandages
Hans Christian Hedrich and Heinz Gulle
Chapter 11. Production and clinical use of human plasma antithrombin III
Andrea Morelli
Chapter 12. Human serum albumin: a multi-functional plasma protein
John More and Mark Bulmer
Chapter 13. Intravenous immunoglobulin G from human plasma – purification concepts and important quality criteria
Andrea Buchacher and Waltraud Kaar
Chapter 14. Hyperimmune IgG
Hugh Price, Maurice Genereux and Christopner Sinclair
Chapter 15. Rh (D) Immunoglobulin
Maurice Genereux, Jodi Smith, William Bees and Christopher Sinclair
Chapter 16. Alpha1-proteinase inhibitor: the disease, the protein, and commercial production
Wytold Lebing
Chapter 17. C1-inhibitor
Jan Over, Christinen Kramer, Anky Koenderman, Diana Wouters and Sache Zeerleder
Chapter 18. Acid-stabilized plasma as a novel direct-acting thrombolytic
Valery Novokhatny, James Rebbeor, Philip Scuderi and Stephen Petteway, Jr.
Chapter 19. Reconstituted, plasma-derived high-density lipoprotein
Peter Lerch
Chapter 20. Plant-derived manufacturing of Apolipoprotein AI Milano: purification and functional characterization
Cory Nykiforuk ,Yin Shen, Elizabeth Murray, Joseph Boothe and Maurice Moloney
Chapter 21. Transferrin
Leni von Bonsdorff, Hennieter Hart, Ingrid Prins-de Nijs, Anky Koenderman, Jan Over and Jaakko Parkkinen
Chapter 22. Plasminogen: its role in the therapy of ligneous conjunctivitis
Claudia Nardini
Chapter 23. Haptoglobin
Joan Dalton and Zuby Okemefuna
Chapter 24. Ceruloplasmin: biology, manufacture, and clinical use
Aron Berkovsky and Vladimir Vaschenko
Chapter 25. Solvent/Detergent plasma
Tor-Einar Svae, Andrea Heger, Lothar Biesert, Andrea Neisser-Svae and Wolfgang Frenzel
3. Pathogen safety of plasma products
26. Ensuring virus safety of plasma products
Herbert Dichtelmüller
Chaprer 27. Transmissible spongiform encephalopathies and plasma products
Luisa Gregori, David Asher and Dorothy Scott
4. The pharmaceutical environment applied to plasma fractionation
Chapter 28. Quality assurance requirements in plasma product manufacture
Jens Jesse
Chapter 29. Regulatory activities associated with production and commercialization of plasma protein therapeutics
Nancy Kirschbaum and Timothy Lee
Chapter 30. The emerging role of global Medical Affairs in the 21st Century
Hartmut Ehrlich, David Perry, David Gelmont and Ramin Farhood
Chapter 31. Plasma for fractionation
Joseph Bertolini and Timothy Hayes
Chapter 32. The pharmaceutical manufacturing environment
Ernst Hetzl
5. The market for plasma products and the economies of fractionation
Chapter 33. The economics of plasma fractionation
Neil Goss and John Curling
Chapter 34. Future trends in the plasma products market
Paolo Marcucci
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