Production of Plasma Proteins for Therapeutic Use

Description

Sets forth the state of the science and technology in plasma protein production

With contributions from an international team of eighty leading experts and pioneers in the field, Production of Plasma Proteins for Therapeutic Use presents a comprehensive overview of the current state of knowledge about the function, use, and production of blood plasma proteins. In addition to details of the operational requirements for the production of plasma derivatives, the book describes the biology, development, research, manufacture, and clinical indications of essentially all plasma proteins with established clinical use or therapeutic potential.

Production of Plasma Proteins for Therapeutic Use covers the key aspects of the plasma fractionation industry in five sections:

• Section 1: Introduction to Plasma Fractionation initially describes the history of transfusion and then covers the emergence of plasma collection and fractionation from its earliest days to the present time, with the commercial and not-for-profit sectors developing into a multi-billion dollar industry.
• Section 2: Plasma Proteins for Therapeutic Use contains 24 chapters dedicated to specific plasma proteins, including coagulation factors, albumin, immunoglobulin, and a comprehensive range of other plasma-derived proteins with therapeutic indications. Each chapter discusses the physiology, biochemistry, mechanism of action, and manufacture of each plasma protein including viral safety issues and clinical uses.
• Section 3: Pathogen Safety of Plasma Products examines issues and procedures for enhancing viral safety and reducing the risk of transmissible spongiform encephalopathy transmission.
• Section 4: The Pharmaceutical Environment Applied to Plasma Fractionation details the requirements and activities associated with plasma collection, quality assurance, compliance with regulatory requirements, provision of medical affairs support, and the manufacture of plasma products.
• Section 5: The Market for Plasma Products and the Economics of Fractionation reviews the commercial environment and economics of the plasma fractionation industry including future trends, highlighting regions such as Asia, which have the potential to exert a major influence on the plasma fractionation industry in the twenty-first century.

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

• Chapter 26. Ensuring virus safety of plasma products
  Herbert Dichtelmüller
• Chapter 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