production of plasma proteins for therapeutic use

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Production Of Plasma Proteins For Therapeutic Use

Author : Joseph Bertolini
ISBN : 9781118356791
Genre : Medical
File Size : 52. 29 MB
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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.

Biotechnology Of Plasma Proteins

Author : Roger L. Lundblad
ISBN : 9781439850275
Genre : Medical
File Size : 55. 89 MB
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The fractionation of human blood plasma can be considered to be a mature industry, with the basic technology, alcohol fractionation, dating back at least to the 1940s. Many of the products described in the current work have been approved biologics since the 1950s. The information gathered from the development of plasma proteins has proved vital to the development of recombinant therapeutic proteins. Discussing the role of plasma proteins in current biotechnology, Biotechnology of Plasma Proteins describes the protein composition of human plasma, the fractionation of plasma to obtain therapeutic proteins, and the analysis of these products. It delineates the path from plasma products to recombinant products, and highlights products from albumin, intravenous immunoglobins, and coagulation. It offers a comprehensive review of current techniques for the analysis of proteins including electrophoresis, chromatography, spectrophotometry, mass spectrometry, and updates not published since 1975. Key Topics Protein Composition of Plasma Proteomic methods for plasma protein analysis Plasma protein biomarkers Validation of biomarkers Assays for plasma biomarkers Methods for the Analysis of Protein Products Assay development and validation Electrophoresis Chromatography Immunoassay Mass spectrometry Raman spectroscopy Plasma Fractionation: Historical and Modern Methods Development of Cohn alcohol fractionation Industrial methods Development of chromatographic methods Plasma Protein Products of Therapeutic Value Albumin Intravenous immunoglobulin Coagulation products Growth factors Wound management

Rossi S Principles Of Transfusion Medicine

Author : Toby L. Simon
ISBN : 9781119013013
Genre : Medical
File Size : 46. 30 MB
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Rossi's Principles of Transfusion Medicine is the most comprehensive and practical reference on transfusion science and medicine available Led by a world class Editor team, including two past-presidents of AABB, a past- President of the American Board of Pathology and members of the FDA Blood Products Advisory Committee , and international contributor team Comprehensive reference resource, considered the gold standard in transfusion Covers current hot topics such as donor care – including the frequency of donation and management of iron deficiency/status), patient blood management, hemovigilance, cstem cell therapies, and global aspects of the organization of transfusion and transplant services New material on molecular immunohematology Companion website includes figures, full text and references

Fusion Protein Technologies For Biopharmaceuticals

Author : Stefan R. Schmidt
ISBN : 9781118354582
Genre : Medical
File Size : 38. 94 MB
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The state of the art in biopharmaceutical FUSION PROTEIN DESIGN Fusion proteins belong to the most lucrative biotech drugs—with Enbrel® being one of the best-selling biologics worldwide. Enbrel® represents a milestone of modern therapies just as Humulin®, the first therapeutic recombinant protein for human use, approved by the FDA in 1982 and Orthoclone® the first monoclonal antibody reaching the market in 1986. These first generation molecules were soon followed by a plethora of recombinant copies of natural human proteins, and in 1998, the first de novo designed fusion protein was launched. Fusion Protein Technologies for Biopharmaceuticals examines the state of the art in developing fusion proteins for biopharmaceuticals, shedding light on the immense potential inherent in fusion protein design and functionality. A wide pantheon of international scientists and researchers deliver a comprehensive and complete overview of therapeutic fusion proteins, combining the success stories of marketed drugs with the dynamic preclinical and clinical research into novel drugs designed for as yet unmet medical needs. The book covers the major types of fusion proteins—receptor-traps, immunotoxins, Fc-fusions and peptibodies—while also detailing the approaches for developing, delivering, and improving the stability of fusion proteins. The main body of the book contains three large sections that address issues key to this specialty: strategies for extending the plasma half life, the design of toxic proteins, and utilizing fusion proteins for ultra specific targeting. The book concludes with novel concepts in this field, including examples of highly relevant multifunctional antibodies. Detailing the innovative science, commercial realities, and brilliant potential of fusion protein therapeutics, Fusion Protein Technologies for Biopharmaceuticals is a must for pharmaceutical scientists, biochemists, medicinal chemists, molecular biologists, pharmacologists, and genetic engineers interested in determining the shape of innovation in the world of biopharmaceuticals.

Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals

Author : Feroz Jameel
ISBN : 9780470595879
Genre : Science
File Size : 66. 32 MB
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A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Applied Biopharmaceutics Pharmacokinetics Seventh Edition

Author : Leon Shargel
ISBN : 9780071829649
Genre : Medical
File Size : 58. 56 MB
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The landmark textbook on the theoretical and practical applications of biopharmaceutics and pharmacokinetics—now fully updated. Explains how to detect clinical pharmacokinetic problems and apply basic pharmacokinetic principles to solve them Helps you critically evaluate biopharmaceutic studies involving drug product equivalency and unequivalency Chapters have been revised to reflect the latest clinical perspectives on drug performance, bioavailability, bioequivalence, pharmacokinetics, pharmacodynamics, and drug therapy The field’s leading text for more than three decades, Applied Biopharmaceutics & Pharmacokinetics gets you up to speed on the basics of the discipline like no other resource. Practical problems and clinical examples with discussions are integrated within each chapter to help you apply principles to patient care and drug consultation situations. In addition, outstanding pedagogy, including chapter objectives, chapter summaries, and FAQs, plus additional application questions, identify and focus on key concepts. Written by authors who have both academic and clinical experience, Applied Biopharmaceutics & Pharmacokinetics shows you how to use raw data and formulate the pharmacokinetic models and parameters that best describe the process of drug absorption, distribution, and elimination. The book also helps you work with pharmacokinetic and biopharmaceutic parameters to design and evaluate dosage regimens of drugs. In the seventh edition of this must-have interactive learning tool, most of the chapters are updated to reflect our current understanding of complex issues associated with safe and efficacious drug therapy.

Supportive Therapy In Haematology

Author : P.C. Das
ISBN : 9781461325772
Genre : Medical
File Size : 41. 77 MB
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