Production of Plasma Proteins for Therapeutic Use

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 Jurgen Romisch and Katharina Pock Chapter 6. Factor IX Salvador Grancha, Steven Herring, Antonio Paez, 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. Alpha 1 -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 Dichtelmuller 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 21 st 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