CiNii 図書 - Production of plasma proteins for therapeutic use

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.

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 Jurgen Roemisch and Katharina Pock 6 Factor IX 81 Salvador Grancha, Steven Herring, Antonio Paez, 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 Intravenous Immunoglobulin G from Human Plasma - Purification Concepts and Important Quality Criteria 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 Alpha 1 -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 AI Milano : 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 Dichtelmuller 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

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Production of plasma proteins for therapeutic use

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