Production of Plasma Proteins for Therapeutic Use

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  • Edition: 1st
  • Format: Hardcover
  • Copyright: 2012-12-26
  • Publisher: Wiley

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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.

Author Biography

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

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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