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This book presents clinical, technical, and commercial information for the plasma fractionation industry. The book starts with a history of the industry that is followed by detailed chapters on all products covering biology, clinical use, manufacturing processes, and possible future improvements. In addition, there are chapters dealing with viral and prion issues and the operational areas including: manufacturing, regulatory, quality, medical information, and commercial evaluation. A final chapter provides a strategic overview and examines commercial, structural, and political opportunities and challenges that confront the industry now and in the future. With contributions from the major manufacturers of plasma proteins, the book is a comprehensive compilation on plasma protein production from the leading experts in the field.
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.
Table of Contents
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