Joseph Bertolini,
J Bertolini,
Neil Goss,
John Curling
e.a.
John Wiley & Sons
e druk, 2013
9780470924310
Production of Plasma Proteins for Therapeutic Use
Specificaties
Gebonden, 512 blz.
|
Engels
John Wiley & Sons |
2013
ISBN13: 9780470924310
Rubricering
Verwachte levertijd ongeveer 16 werkdagen
Gratis verzonden
Samenvatting
A comprehensive compilation on plasma protein production from the leading experts in the field,
Production of Plasma Proteins for Therapeutic Use presents manufacturing, testing methods, and regulatory issues for plasma–derived therapeutics, a global US$10 billion industry. Culling material that until now have only been available in scattered forms across journals and books, the text features twenty–three detailed protein–by–protein chapters written by the major manufacturers of plasma protein products, addressing all aspects of these proteins, including biology, clinical use, manufacturing processes, and possible future improvements.
Specificaties
Inhoudsopgave
<p>PREFACE ix</p>
<p>CONTRIBUTORS xi</p>
<p>SECTION 1 INTRODUCTION TO PLASMA FRACTIONATION</p>
<p>1 The History and Development of the Plasma Protein Fractionation Industry 3<br /> John Curling, Neil Goss, and Joseph Bertolini</p>
<p>SECTION 2 PLASMA PROTEINS FOR THERAPEUTIC USE</p>
<p>2 Production and Clinical Profile of Human Plasma Coagulation Factor VIII 31<br /> Sami Chtourou</p>
<p>3 Production and Clinical Profile of Human Plasma–Derived Von Willebrand Factor 41<br /> Sami Chtourou and Michel Poulle</p>
<p>4 Factor Eight Inhibitor Bypassing Activity 49<br /> Peter Turecek and Hans Peter Schwarz</p>
<p>5 Prothrombin Complex 65<br /> Jürgen Römisch and Katharina Pock</p>
<p>6 Factor IX 81<br /> Salvador Grancha, Steven Herring, Antonio Pa´ez, Pere Ristol, and Juan Ignacio Jorquera</p>
<p>7 Factor XI 93<br /> Sami Chtourou and Michel Poulle</p>
<p>8 Factor XIII and Factor X 101<br /> Peter Feldman</p>
<p>9 Fibrinogen: Science and Biotechnology 117<br /> Gerard Marx</p>
<p>10 Fibrin Glues and Bandages 137<br /> Hans Christian Hedrich and Heinz Gulle</p>
<p>11 Production and Clinical Use of Plasma Antithrombin III 147<br /> Andrea Morelli</p>
<p>12 Human Serum Albumin: A Multifunctional Plasma Protein 159<br /> John More and Mark Bulmer</p>
<p>13 IntravenousImmunoglobulinGfromHumanPlasma Purification Concepts and Important QualityCriteria 185<br /> Andrea Buchacher and Waltraud Kaar</p>
<p>14 Hyperimmune Immunoglobulin G 207<br /> Hugh Price, Maurice Genereux, and Christopher Sinclair</p>
<p>15 Rh (D) Immunoglobulin 217<br /> Maurice Genereux, Jodi Smith, William Bees, and Christopher Sinclair</p>
<p>16 Alpha1–Proteinase Inhibitor: The Disease, the Protein, and Commercial Production 227<br /> Wytold Lebing</p>
<p>17 C1–Inhibitor 241<br /> Jan Over, Christine Kramer, Anky Koenderman, Diana Wouters, and Sacha Zeerleder</p>
<p>18 Acid–Stabilized Plasmin as a Novel Direct–Acting Thrombolytic 259<br /> Valery Novokhatny, James Rebbeor, Philip Scuderi, and Stephen Petteway Jr.</p>
<p>19 Reconstituted, Plasma–Derived High–Density Lipoprotein 273<br /> Peter Lerch</p>
<p>20 Plant–Derived Manufacturing of Apolipoprotein AIMilano: Purification and Functional Characterization 283<br /> Cory Nykiforuk, Yin Shen, Elizabeth Murray, Joseph Boothe, and Maurice Moloney</p>
<p>21 Transferrin 301<br /> Leni von Bonsdorff, Hennie ter Hart, Ingrid Prins–de Nijs, Anky Koenderman, Jan Over, and Jaakko Parkkinen</p>
<p>22 Plasminogen: Its Role in the Therapy of Ligneous Conjunctivitis 311<br /> Claudia Nardini</p>
<p>23 Haptoglobin 321<br /> Joan Dalton and Azubuike Okemefuna</p>
<p>24 Ceruloplasmin: Biology, Manufacture, and Clinical Use 337<br /> Aron Berkovsky and Vladimir Vaschenko</p>
<p>25 Solvent/Detergent Plasma 345<br /> Tor–Einar Svae, Andrea Heger, Lothar Biesert, Andrea Neisser–Svae, and Wolfgang Frenzel</p>
<p>SECTION 3 PATHOGEN SAFETY OF PLASMA PRODUCTS</p>
<p>26 Ensuring Virus Safety of Plasma Products 361<br /> Herbert Dichtelmu¨ller</p>
<p>27 Transmissible Spongiform Encephalopathies and Plasma Products 369<br /> Luisa Gregori, David Asher, and Dorothy Scott</p>
<p>SECTION 4 THE PHARMACEUTICAL ENVIRONMENT APPLIED TO PLASMA FRACTIONATION</p>
<p>28 Quality Assurance Requirements in Plasma Product Manufacture 383<br /> Jens Jesse</p>
<p>29 Regulatory Activities Associated with Production and Commercialization of Plasma Protein Therapeutics 403<br /> Nancy Kirschbaum and Timothy Lee</p>
<p>30 The Emerging Role of Global Medical Affairs in the Twenty–First Century 413<br /> Hartmut Ehrlich, David Perry, David Gelmont, and Ramin Farhood</p>
<p>31 Plasma for Fractionation 423<br /> Joseph Bertolini and Timothy Hayes</p>
<p>32 The Pharmaceutical Manufacturing Environment 437<br /> Ernst Hetzl</p>
<p>SECTION 5 THE MARKET FOR PLASMA PRODUCTS AND THE ECONOMICS OF FRACTIONATION</p>
<p>33 The Economics of Plasma Fractionation 451<br /> Neil Goss and John Curling</p>
<p>34 Future Trends in the Plasma Products Market 461<br /> Paolo Marcucci</p>
<p>INDEX 471</p>
<p>CONTRIBUTORS xi</p>
<p>SECTION 1 INTRODUCTION TO PLASMA FRACTIONATION</p>
<p>1 The History and Development of the Plasma Protein Fractionation Industry 3<br /> John Curling, Neil Goss, and Joseph Bertolini</p>
<p>SECTION 2 PLASMA PROTEINS FOR THERAPEUTIC USE</p>
<p>2 Production and Clinical Profile of Human Plasma Coagulation Factor VIII 31<br /> Sami Chtourou</p>
<p>3 Production and Clinical Profile of Human Plasma–Derived Von Willebrand Factor 41<br /> Sami Chtourou and Michel Poulle</p>
<p>4 Factor Eight Inhibitor Bypassing Activity 49<br /> Peter Turecek and Hans Peter Schwarz</p>
<p>5 Prothrombin Complex 65<br /> Jürgen Römisch and Katharina Pock</p>
<p>6 Factor IX 81<br /> Salvador Grancha, Steven Herring, Antonio Pa´ez, Pere Ristol, and Juan Ignacio Jorquera</p>
<p>7 Factor XI 93<br /> Sami Chtourou and Michel Poulle</p>
<p>8 Factor XIII and Factor X 101<br /> Peter Feldman</p>
<p>9 Fibrinogen: Science and Biotechnology 117<br /> Gerard Marx</p>
<p>10 Fibrin Glues and Bandages 137<br /> Hans Christian Hedrich and Heinz Gulle</p>
<p>11 Production and Clinical Use of Plasma Antithrombin III 147<br /> Andrea Morelli</p>
<p>12 Human Serum Albumin: A Multifunctional Plasma Protein 159<br /> John More and Mark Bulmer</p>
<p>13 IntravenousImmunoglobulinGfromHumanPlasma Purification Concepts and Important QualityCriteria 185<br /> Andrea Buchacher and Waltraud Kaar</p>
<p>14 Hyperimmune Immunoglobulin G 207<br /> Hugh Price, Maurice Genereux, and Christopher Sinclair</p>
<p>15 Rh (D) Immunoglobulin 217<br /> Maurice Genereux, Jodi Smith, William Bees, and Christopher Sinclair</p>
<p>16 Alpha1–Proteinase Inhibitor: The Disease, the Protein, and Commercial Production 227<br /> Wytold Lebing</p>
<p>17 C1–Inhibitor 241<br /> Jan Over, Christine Kramer, Anky Koenderman, Diana Wouters, and Sacha Zeerleder</p>
<p>18 Acid–Stabilized Plasmin as a Novel Direct–Acting Thrombolytic 259<br /> Valery Novokhatny, James Rebbeor, Philip Scuderi, and Stephen Petteway Jr.</p>
<p>19 Reconstituted, Plasma–Derived High–Density Lipoprotein 273<br /> Peter Lerch</p>
<p>20 Plant–Derived Manufacturing of Apolipoprotein AIMilano: Purification and Functional Characterization 283<br /> Cory Nykiforuk, Yin Shen, Elizabeth Murray, Joseph Boothe, and Maurice Moloney</p>
<p>21 Transferrin 301<br /> Leni von Bonsdorff, Hennie ter Hart, Ingrid Prins–de Nijs, Anky Koenderman, Jan Over, and Jaakko Parkkinen</p>
<p>22 Plasminogen: Its Role in the Therapy of Ligneous Conjunctivitis 311<br /> Claudia Nardini</p>
<p>23 Haptoglobin 321<br /> Joan Dalton and Azubuike Okemefuna</p>
<p>24 Ceruloplasmin: Biology, Manufacture, and Clinical Use 337<br /> Aron Berkovsky and Vladimir Vaschenko</p>
<p>25 Solvent/Detergent Plasma 345<br /> Tor–Einar Svae, Andrea Heger, Lothar Biesert, Andrea Neisser–Svae, and Wolfgang Frenzel</p>
<p>SECTION 3 PATHOGEN SAFETY OF PLASMA PRODUCTS</p>
<p>26 Ensuring Virus Safety of Plasma Products 361<br /> Herbert Dichtelmu¨ller</p>
<p>27 Transmissible Spongiform Encephalopathies and Plasma Products 369<br /> Luisa Gregori, David Asher, and Dorothy Scott</p>
<p>SECTION 4 THE PHARMACEUTICAL ENVIRONMENT APPLIED TO PLASMA FRACTIONATION</p>
<p>28 Quality Assurance Requirements in Plasma Product Manufacture 383<br /> Jens Jesse</p>
<p>29 Regulatory Activities Associated with Production and Commercialization of Plasma Protein Therapeutics 403<br /> Nancy Kirschbaum and Timothy Lee</p>
<p>30 The Emerging Role of Global Medical Affairs in the Twenty–First Century 413<br /> Hartmut Ehrlich, David Perry, David Gelmont, and Ramin Farhood</p>
<p>31 Plasma for Fractionation 423<br /> Joseph Bertolini and Timothy Hayes</p>
<p>32 The Pharmaceutical Manufacturing Environment 437<br /> Ernst Hetzl</p>
<p>SECTION 5 THE MARKET FOR PLASMA PRODUCTS AND THE ECONOMICS OF FRACTIONATION</p>
<p>33 The Economics of Plasma Fractionation 451<br /> Neil Goss and John Curling</p>
<p>34 Future Trends in the Plasma Products Market 461<br /> Paolo Marcucci</p>
<p>INDEX 471</p>