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Production of Plasma Proteins for Therapeutic Use by Joseph Bertolini, Neil Goss and John Curling (Editors), Wiley, 496 pages, ISBN 978-0-470-92431-0978-0-470-92431-0

Kjell Eriksson kjell.eriksson@ge.com*, * GE Healthcare, Uppsala, Sweden

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This book is long overdue. Until now, there has never been a book available that is as comprehensive for the plasma area. It covers the topics of the biology of plasma proteins and their production, from blood plasma collection to finished products, and also gives a description of these products' clinical use. I fully agree with the editors (J. Bertolini, N. Goss, and J. Curling) in their statement about the book: “It will be an invaluable reference for, not only those directly connected with the development of plasma protein therapies, but also for those in the multiple vendor and service industries that make possible the manufacture of safe and efficacious plasma products”.

The book consists of five sections, where the first, “The History and Evolution of Plasma Protein Fractionation”, as the title implies, deals with the development of plasma fractionation and includes a description of the pioneering work of E. J. Cohn and his collaborators. The impact of the work conducted by Cohn and his colleagues cannot be overestimated. A description of the development and consolidation of the plasma industry is also included. The first section is a perfect introduction to the rest of the book.

Section two, “Plasma Proteins for Therapeutic Use”, describes in detail the most important plasma proteins. Each chapter, of the total 24 in this section, discusses the physiology, biochemistry, mechanism of action, manufacture (including viral safety issues), clinical use of, as well as future trends in plasma proteins. Eventhough each chapter is written by different authors, they are, in the majority of the cases, written in a consistent way and at a uniform level. This must be acknowledged to the editors, which have done a tremendous job aligning all these different chapters. Overall, section two is very useful, with its detailed discussions of Factor VIII, von Willebrand Factor, Protrombin Complex, Factor IX, Factor XI, Factor XIII and Factor X, Fibrinogen, Fibrin Glues, Antithrombin III, Albumin, Intravenous Immunoglobulin G, Hyperimmune Immunoglobulin G, Rh (D) Immunoglobulin G, Alpha1-Proteinase Inhibitor, C1-Inhibitor, Plasmin, High-Density Lipoprotein, Apolipoprotein AIMilano (transgenic), Transferrin, Plasminogen, Haptoglobulin, Cerruloplasmin, as well as Solvent/Detergent Plasma. The chapters in this section will be read and referred to for many years to come. This section illustrates the complexity of the human plasma protein system and the many and varied proteins involved, the intricate actions and balance of the different components, as well as the physiological implications when something in this system is not functioning. As all details of the plasma protein system are not yet known, there is still much to be discovered.

“It will be an invaluable reference not only for those directly connected with the development of plasma protein therapies, but also for those in the multiple vendor and service industries that make possible the manufacture of safe and efficacious plasma products.”

Despite the excellent work, additional some points would have made section two even more valuable. From an economic perspective, intravenous immunoglobulin G is the most valuable of all the protein processed from plasma. The chapter covering this protein, its clinical use and surrounding issues, could have been more detailed. More information of future trends, such as the much anticipated use of intravenous immunoglobulin G in the treatment of Alzheimer's disease, could also have deserved more space. In addition, there is one chapter describing a protein produced in a transgenic plant. This is an interesting topic but if plasma proteins produced in recombinant systems should have been described at all in this book, recombinant plasma proteins in general could have been discussed in a separate chapter and not been limited to this one specific case.

The third section, “Pathogen Safety of Plasma”, is a very important section with two chapters: One highlighting the demands of working with the unique starting material – the human plasma, and one highlighting the need for donor selection, testing, and control of both virus and prion safety and describing pathogen inactivation and removal procedures. The book would have benefited from a more detailed discussion of this particular subject.

“...this will be the standard book in plasma protein production for at least one generation of stakeholders in the field...”

Section four, “The Pharmaceutical Environment Applied to Plasma Frationation”, describes “auxiliary” activities related to the plasma industry, such as plasma collection, quality assurance and compliance with regulatory requirements, medical affairs support, and the manufacture of plasma products. This is a well-rounded section that gives a good overview of the area. An added value to this section is the table describing the different, and often difficult to understand, nomenclature surrounding plasma.

The last section, “The Market for Plasma Products and the Economics of Fractionation”, consist of two chapters. The first chapter, describing the economics of plasma production often referred to as “last liter economics”, gives a thorough explanation of the need for not only high-yield production, but also for a multiproduct plasma manufacturing facility. The second chapter in this section focuses on the future of the plasma industry. Overall, this is a good chapter but a more detailed discussion of the somewhat contradictory trends in the industry, such as consolidation of the plasma industry in developed countries (with three main players) and the emergence of smaller plasma production plants that supply local markets in the developing countries, would have been preferred.

The book comprises close to 500 pages of useful information and will be the standard book in plasma protein production for at least one generation of stakeholders in the plasma protein area. But it should in no way be considered that this is the final word in this field. There is still much more to be learned about the complex story of plasma proteins, their biochemistry, and their clinical use.

Kjell Eriksson, GE Healthcare, Uppsala, Sweden, E-mail: kjell.eriksson@ge.com

About the book editors

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Dr. Joseph Bertolini is R&D manager at CSL Behring (Australia) and has been closely involved in the technical development and improvement of the immunoglobulin and albumin products currently manufactured at CSL Behring 9Australia) – Intragam P and Albumex. He continues to explore manufacturing processes with the aim of improving through-put and yield through the adoption of new technologies in particular the area of chromatography. He is also interested in establishing and adopting new techniques for studying the physiochemical and biological properties of proteins as a means of establishing product comparability and ensuring product function and safety. As a result he maintains an active collaboration with external institutes as a means of accessing new technological and conceptual advances. He is interested in advancing the field of bioprocessing and contributes to the activities of a number of national and international conference and industry organizations.

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Dr. Neil Goss obtained his PhD in Biochemistry and Protein Chemistry from Adelaide University in Australia. After working as a postdoctoral fellow and then on the faculty at Case Western Reserve University in Cleveland, Ohio he joined Ingene Inc. in Santa Monica, California and then Biotechnology Australia in Sydney, Australia. He subsequently became Director of Research and Development at CSL Bioplasma before establishing Further Options Pty. Ltd. in Melbourne, Australia in 1998. Dr Goss' interests lie in assisting and advancing the establishment of high quality plasma fractionation facilities in the developing world. Further Options has been involved in a wide range of activities related to biotechnology and plasma fractionation and engaged in projects in China, South East Asia, the Middle East and the Americas. Dr Goss has over 40 peers reviewed publications and twelve patents and is the co-founder of the Plasma Product Biotechnology Conference series and the BioProcessing Network Inc.

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John Curling graduated in chemistry from The University of Sussex, UK in 1965 and joined Pharmacia Fine Chemicals, the leading bioseparations company, in 1967. Following an intense period of research on blood plasma protein purification from 1972 to 1982, he became President of Pharmacia's Process Separation Division. The chromatographic fractionation methods developed by his group have now been integrated into most downstream processes for the manufacture of plasma proteins for therapeutic use. He was editor of “Methods of Plasma Protein Fractionation” published in 1980 and is the author of numerous publications on the separation of recombinant and plasma derived proteins. Since 1990 John Curling has worked as a consultant to the blood plasma, biopharmaceutical and vendor industries. He continues to be active in the development of the recovery of biological products and maintains a special interest in establishing plasma fractionation in Asia's developing countries.