Production of Plasma Proteins for Therapeutic Use

Description

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