Production of Plasma Proteins for Therapeutic Use

08.02.2013

Englisch

9780470924310

John Wiley & Sons

Nein

Joseph Bertolini

512

Gebundene Ausgabe

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.

Biotechnologie i. d. Biowissenschaften, Biotechnology, Biowissenschaften, Chemie, Chemistry, Drug Discovery & Development, Hämatologie, Hematology, Life Sciences, Medical Science, Medizin, Wirkstoffforschung, Wirkstoffforschung u. -entwicklung

PNB - Medizinische Chemie, Pharmazeutische Chemie

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 Pa´ez, 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 Dichtelmu¨ller 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

288 mm

21.9 cm