Joseph Bertolini, Neil Goss, John Curling

Production of Plasma Proteins for Therapeutic Use (eBook, ePUB)

• Format: ePub

Produktbeschreibung

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.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 512
• Erscheinungstermin: 6. Dezember 2012
• Englisch
• ISBN-13: 9781118356791
• Artikelnr.: 37347557

Autorenporträt

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.

Inhaltsangabe

PREFACE ix CONTRIBUTORS xi SECTION 1 INTRODUCTION TO PLASMA FRACTIONATION 1
The History and Development of the Plasma Protein Fractionation Industry 3
John Curling, Neil Goss, and Joseph Bertolini SECTION 2 PLASMA PROTEINS FOR
THERAPEUTIC USE 2 Production and Clinical Profile of Human Plasma
Coagulation Factor VIII 31 Sami Chtourou 3 Production and Clinical Profile
of Human Plasma-Derived Von Willebrand Factor 41 Sami Chtourou and Michel
Poulle 4 Factor Eight Inhibitor Bypassing Activity 49 Peter Turecek and
Hans Peter Schwarz 5 Prothrombin Complex 65 Jürgen Römisch and Katharina
Pock 6 Factor IX 81 Salvador Grancha, Steven Herring, Antonio Päez, Pere
Ristol, and Juan Ignacio Jorquera 7 Factor XI 93 Sami Chtourou and Michel
Poulle 8 Factor XIII and Factor X 101 Peter Feldman 9 Fibrinogen: Science
and Biotechnology 117 Gerard Marx 10 Fibrin Glues and Bandages 137 Hans
Christian Hedrich and Heinz Gulle 11 Production and Clinical Use of Plasma
Antithrombin III 147 Andrea Morelli 12 Human Serum Albumin: A
Multifunctional Plasma Protein 159 John More and Mark Bulmer 13
IntravenousImmunoglobulinGfromHumanPlasma-Purification Concepts and
Important QualityCriteria 185 Andrea Buchacher and Waltraud Kaar 14
Hyperimmune Immunoglobulin G 207 Hugh Price, Maurice Genereux, and
Christopher Sinclair 15 Rh (D) Immunoglobulin 217 Maurice Genereux, Jodi
Smith, William Bees, and Christopher Sinclair 16 Alpha1-Proteinase
Inhibitor: The Disease, the Protein, and Commercial Production 227 Wytold
Lebing 17 C1-Inhibitor 241 Jan Over, Christine Kramer, Anky Koenderman,
Diana Wouters, and Sacha Zeerleder 18 Acid-Stabilized Plasmin as a Novel
Direct-Acting Thrombolytic 259 Valery Novokhatny, James Rebbeor, Philip
Scuderi, and Stephen Petteway Jr. 19 Reconstituted, Plasma-Derived
High-Density Lipoprotein 273 Peter Lerch 20 Plant-Derived Manufacturing of
Apolipoprotein AIMilano: Purification and Functional Characterization 283
Cory Nykiforuk, Yin Shen, Elizabeth Murray, Joseph Boothe, and Maurice
Moloney 21 Transferrin 301 Leni von Bonsdorff, Hennie ter Hart, Ingrid
Prins-de Nijs, Anky Koenderman, Jan Over, and Jaakko Parkkinen 22
Plasminogen: Its Role in the Therapy of Ligneous Conjunctivitis 311 Claudia
Nardini 23 Haptoglobin 321 Joan Dalton and Azubuike Okemefuna 24
Ceruloplasmin: Biology, Manufacture, and Clinical Use 337 Aron Berkovsky
and Vladimir Vaschenko 25 Solvent/Detergent Plasma 345 Tor-Einar Svae,
Andrea Heger, Lothar Biesert, Andrea Neisser-Svae, and Wolfgang Frenzel
SECTION 3 PATHOGEN SAFETY OF PLASMA PRODUCTS 26 Ensuring Virus Safety of
Plasma Products 361 Herbert Dichtelmüller 27 Transmissible Spongiform
Encephalopathies and Plasma Products 369 Luisa Gregori, David Asher, and
Dorothy Scott SECTION 4 THE PHARMACEUTICAL ENVIRONMENT APPLIED TO PLASMA
FRACTIONATION 28 Quality Assurance Requirements in Plasma Product
Manufacture 383 Jens Jesse 29 Regulatory Activities Associated with
Production and Commercialization of Plasma Protein Therapeutics 403 Nancy
Kirschbaum and Timothy Lee 30 The Emerging Role of Global Medical Affairs
in the Twenty-First Century 413 Hartmut Ehrlich, David Perry, David
Gelmont, and Ramin Farhood 31 Plasma for Fractionation 423 Joseph Bertolini
and Timothy Hayes 32 The Pharmaceutical Manufacturing Environment 437 Ernst
Hetzl SECTION 5 THE MARKET FOR PLASMA PRODUCTS AND THE ECONOMICS OF
FRACTIONATION 33 The Economics of Plasma Fractionation 451 Neil Goss and
John Curling 34 Future Trends in the Plasma Products Market 461 Paolo
Marcucci INDEX 471