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.

"Blood transfusion is a life-saving intervention that has an essential role in patient management within health care systems. All Member States of the World Health Organization (WHO) endorsed World Health Assembly resolutions WHA28.72 (1) in 1975 and WHA58.13 (2) in 2005. These commit them to the provision of adequate supplies of safe blood and blood products that are accessible to all patients who require transfusion either to save their lives or promote their continuing or improving health." --Preface.

This book deals with the cellular and plasma components of blood and describes the various procedures for their separation/fractionation. Coverage is also extended to the principal cellular elements of blood and the major plasma proteins that are used clinically. Also, detailed consideration is given to the testing for and inactivation of viral contaminants of blood.

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations to assure the quality safety and efficacy of vaccines blood products and other biological medicines and the establishment of international biological reference standards for these products and related diagnostic devices. The report of particular relevance to manufacturers and national regulatory authorities starts with a discussion of general issues brought to the Committee's attention. The second part of the report contains written specifications that establish international regulatory expectations for the following products; DNA vaccines pertussis (whole cell) vaccine plasma (human) for fractionation rabies vaccine and rotavirus vaccine. The report also provides a risk assessment and defines conditions for the safe production of pandemic strain influenza vaccines. The third part of the report provides information on the status and development of international reference materials for various antibodies antigens blood products and related substances and in vitro diagnostic devices.