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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:
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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.
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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.
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Section 3: Pathogen Safety of Plasma Products
examines issues and procedures for enhancing viral safety
and reducing the risk of transmissible spongiform
encephalopathy transmission.
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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.
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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.
Content:
Chapter 1 The History and Development of the Plasma Protein
Fractionation Industry (pages 1–28): John Curling, Neil Goss
and Joseph Bertolini
Chapter 2 Production and Clinical Profile of Human Plasma
Coagulation Factor VIII (pages 29–40): Sami Chtourou
Chapter 3 Production and Clinical Profile of Human
Plasma?Derived Von Willebrand Factor (pages 41–48): Sami
Chtourou and Michel Poulle
Chapter 4 Factor Eight Inhibitor Bypassing Activity (pages
49–63): Peter Turecek and Hans Peter Schwarz
Chapter 5 Prothrombin Complex (pages 65–79): Jurgen Romisch and
Katharina Pock
Chapter 6 Factor IX (pages 81–92): Salvador Grancha, Steven
Herring, Antonio Paez, Pere Ristol and Juan Ignacio
Jorquera
Chapter 7 Factor XI (pages 93–99): Sami Chtourou and Michel
Poulle
Chapter 8 Factor XIII and Factor X (pages 101–115): Peter
Feldman
Chapter 9 Fibrinogen: Science and Biotechnology (pages
117–135): Gerard Marx
Chapter 10 Fibrin Glues and Bandages (pages 137–145): Hans
Christian Hedrich and Heinz Gulle
Chapter 11 Production and Clinical Use of Plasma Antithrombin
III (pages 147–157): Andrea Morelli
Chapter 12 Human Serum Albumin: A Multifunctional Plasma
Protein (pages 159–183): John More and Mark Bulmer
Chapter 13
IntravenousImmunoglobulinGfromHumanPlasma–Purification Concepts
and Important Quality Criteria (pages 185–205): Andrea
Buchacher and Waltraud Kaar
Chapter 14 Hyperimmune Immunoglobulin G (pages 207–216): Hugh
Price, Maurice Genereux and Christopher Sinclair
Chapter 15 Rh (D) Immunoglobulin (pages 217–225): Maurice
Genereux, Jodi Smith, William Bees and Christopher
Sinclair
Chapter 16 Alpha1?Proteinase Inhibitor: The Disease, the
Protein, and Commercial Production (pages 227–240): Wytold
Lebing
Chapter 17 C1?Inhibitor (pages 241–258): Jan Over, Christine
Kramer, Anky Koenderman, Diana Wouters and Sacha
Zeerleder
Chapter 18 Acid?Stabilized Plasmin as a Novel Direct?Acting
Thrombolytic (pages 259–271): Valery Novokhatny, James Rebbeor,
Philip Scuderi and Stephen Petteway
Chapter 19 Reconstituted, Plasma?Derived High?Density
Lipoprotein (pages 273–282): Peter Lerch
Chapter 20 Plant?Derived Manufacturing of Apolipoprotein
AIMilano: Purification and Functional Characterization (pages
283–300): Cory Nykiforuk, Yin Shen, Elizabeth Murray, Joseph
Boothe and Maurice Moloney
Chapter 21 Transferrin (pages 301–310): Leni von Bonsdorff,
Hennie ter Hart, Ingrid Prins?De Nijs, Anky Koenderman, Jan
Over and Jaakko Parkkinen
Chapter 22 Plasminogen: Its Role in the Therapy of Ligneous
Conjunctivitis (pages 311–320): Claudia Nardini
Chapter 23 Haptoglobin (pages 321–336): Joan Dalton and
Azubuike Okemefuna
Chapter 24 Ceruloplasmin: Biology, Manufacture, and Clinical
Use (pages 337–344): Aron Berkovsky and Vladimir
Vaschenko
Chapter 25 Solvent/Detergent Plasma (pages 345–357): Tor?Einar
Svae, Andrea Heger, Lothar Biesert, Andrea Neisser?Svae and
Wolfgang Frenzel
Chapter 26 Ensuring Virus Safety of Plasma Products (pages
359–368): Herbert Dichtelmuller
Chapter 27 Transmissible Spongiform Encephalopathies and Plasma
Products (pages 369–380): Luisa Gregori, David Asher and
Dorothy Scott
Chapter 28 Quality Assurance Requirements in Plasma Product
Manufacture (pages 381–401): Jens Jesse
Chapter 29 Regulatory Activities Associated with Production and
Commercialization of Plasma Protein Therapeutics (pages
403–411): Nancy Kirschbaum and Timothy Lee
Chapter 30 The Emerging Role of Global Medical Affairs in the
Twenty?First Century (pages 413–422): Hartmut Ehrlich, David
Perry, David Gelmont and Ramin Farhood
Chapter 31 Plasma for Fractionation (pages 423–436): Joseph
Bertolini and Timothy Hayes
Chapter 32 The Pharmaceutical Manufacturing Environment (pages
437–448): Ernst Hetzl
Chapter 33 The Economics of Plasma Fractionation (pages
449–460): Neil Goss and John Curling
Chapter 34 Future Trends in the Plasma Products Market (pages
461–470): Paolo Marcucci