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 : 38. 36 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 : 42. 16 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

Fusion Protein Technologies For Biopharmaceuticals

Author : Stefan R. Schmidt
ISBN : 9781118354582
Genre : Medical
File Size : 26. 99 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.

Clinical Trials Audit Preparation

Author : Vera Mihajlovic-Madzarevic
ISBN : 0470920882
Genre : Medical
File Size : 71. 70 MB
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A must-have guide for any professional in the drug manufacturing industry The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals. Among the topics discussed: Good Clinical Practices and therapeutic product development in clinical research The roles of the sponsor of a clinical investigation, the IRB, or independent ethics committee The roles and responsibilities of the clinical trial investigator The inspection preparation The Audit Report and the Form 483 Warning letters issued to clinical investigators and clinical trial sponsors and their impact on product development

Medicines From Animal Cell Culture

Author : Glyn N. Stacey
ISBN : 0470723785
Genre : Science
File Size : 62. 60 MB
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Medicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin. It also addresses the recent dramatic expansion in cell-based therapies, including the use of live cells for tissue regeneration and the culture of stem cells. Medicines from Animal Cell Culture: Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservation and characterisation of both the cells and the derived products Describes the preparation of stem cells and others for use in cell-based therapies – an area of burgeoning research Includes experimental examples to indicate expected results Covers regulatory issues from the UK, the EU and the USA and reviews how these are developing around the world Addresses the key issues of standardisation and validation with chapters on GLP and GMP for cell culture processes Delivering insight into the exciting world of biological medicines and directions for further investigation into specific topics, Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries. It is of value to laboratory managers in these industries and to all those interested in this topic alike.

Rossi S Principles Of Transfusion Medicine

Author : Toby L. Simon
ISBN : 9781119013013
Genre : Medical
File Size : 32. 58 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

Protein Hydrolysates In Biotechnology

Author : Vijai K. Pasupuleti
ISBN : 1402066740
Genre : Science
File Size : 24. 85 MB
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Protein hydrolysates, otherwise commonly known as peptones or peptides, are used in a wide variety of products in fermentation and biotechnology industries. The term “peptone” was first introduced in 1880 by Nagelli for growing bacterial cultures. However, later it was discovered that peptones derived from the partial digestion of proteins would furnish organic nitrogen in readily available form. Ever since, p- tones, which are commonly known as protein hydrolysates, have been used not only for growth of microbial cultures, but also as nitrogen source in commercial fermen- tions using animal cells and recombinant microorganisms for the production of value added products such as therapeutic proteins, hormones, vaccines, etc. Today, the characterization, screening and manufacturing of protein hyd- lysates has become more sophisticated, with the introduction of reliable analytical instrumentation, high throughput screening techniques coupled with statistical design approaches, novel enzymes and efficient downstream processing equipment. This has enabled the introduction of custom-built products for specialized appli- tions in diverse fields of fermentation and biotechnology, such as the following. 1. Protein hydrolysates are used as much more than a simple nitrogen source. For example, the productivities of several therapeutic drugs made by animal cells and recombinant microorganisms have been markedly increased by use of p- tein hydrolysates. This is extremely important when capacities are limited. 2. Protein hydrolysates are employed in the manufacturing of vaccines by ferm- tation processes and also used as vaccine stabilizers.

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