Author: Klaus Dembowsky
Publisher: John Wiley & Sons
ISBN: 9783527302703
Category : Medical
Languages : en
Pages : 388
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Book Description
This book describes medical applications of recombinant proteins and monoclonal antibodies, some of which have already been on the market for several years while others have only recently been launched. It also highlights the manufacturing processes for individual products, the strategies that were taken by companies in the clinical development, and the hurdles that were encountered in clinical trials and had to be overcome before approval by regulatory authorities. Finally, this book illustrates strategies to modify and improve the pharmacodynamic and pharmacokinetic properties of naturally occurring proteins thus paving the way for a new era in biotechnology. Foreword written by Jürgen Drews.
Author:
Publisher: Academic Press
ISBN: 012814341X
Category : Science
Languages : en
Pages : 410
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Book Description
Therapeutic Proteins and Peptides, Volume 112 in an ongoing series promotes further research in the discovery of new therapeutic targets that can be affected by therapeutic proteins and peptides to cure or manage symptoms of human diseases, with this release focusing on the Rational Design of Stable Liquid Formulations of Biopharmaceuticals, Formulation strategies for peptides, proteins and antibodies using nanotechnology, the Solution structural dynamics of therapeutic peptides and their adsorption on plasmonic nanoparticles, Enzymatic approaches of protein-polymer conjugation, Chimeric small antibody fragments as a strategy to deliver therapeutic payloads, Smart cell-penetrating peptide-based techniques for cytoplasmic delivery of therapeutic macromolecules, and more. - Describes advances in the discovery and application of therapeutic proteins/peptides which allow better targeting to the site of treatment and cause fewer adverse effects when compared to chemical compounds used for disease treatment - Targeted to a very wide audience of specialists, researchers and students - Written by well-renown authorities in their field - Includes a number of high quality illustrations, figures and tables
Author: Joseph Bertolini
Publisher: John Wiley & Sons
ISBN: 0470924314
Category : Medical
Languages : en
Pages : 518
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Book Description
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.
Author: Oliver Kayser
Publisher: John Wiley & Sons
ISBN: 3527329943
Category : Science
Languages : en
Pages : 677
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Book Description
This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.
Author: Honghui Zhou
Publisher: John Wiley & Sons
ISBN: 111889880X
Category : Medical
Languages : en
Pages : 479
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Book Description
With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain
Author: Steven M. Chamow
Publisher: John Wiley & Sons
ISBN: 3527675280
Category : Science
Languages : en
Pages : 345
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Book Description
Edited by three pioneers in the field, each with longstanding experience in the biotech industry, and a skilled scientific writer, this is the first book to cover every step in the development and production of immunoglobulin Fc-fusion proteins as therapeutics for human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion proteins that are now commercially successful products. In this section, the authors, several of whom were personally involved in clinical development of the products themselves, detail the product?s background and give insight into issues that were faced and how these issues were overcome during clinical development. This section also includes a chapter on promising new developments for the future. An invaluable resource for professionals already working on Fc-fusion proteins and an excellent and thorough introduction for physicians, researchers, and students entering the field.
Author: Allan Matte
Publisher: Elsevier
ISBN: 0081030193
Category : Medical
Languages : en
Pages : 222
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Book Description
Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book.
Author: Pawan Kumar Maurya
Publisher: Academic Press
ISBN: 032390906X
Category : Science
Languages : en
Pages : 294
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Book Description
Novel Therapeutic Approaches Targeting Oxidative Stress investigates the role of oxidative stress in disease and explores the latest methods and approaches to targeting oxidative stress for treatment and diagnosis. The book begins with an introduction to oxidative stress and its significance. Subsequent sections cover biochemical methods for detecting free radicals and novel therapeutic approaches for targeting oxidative stress in a number of different diseases. This includes age-related illnesses, neuropsychiatric disorders such as schizophrenia and bipolar disorder, and neurodegenerative diseases like Alzheimer's and Parkinson's disease. Novel approaches for targeting oxidative stress in cancer and cardiovascular diseases are also explored. The book then moves on to discuss advances in drug delivery systems and detecting oxidative stress biomarkers using biosensors. It concludes with case studies that illustrate the targeting of oxidative stress and future perspectives. - Explores oxidative stress in a variety of diseases, including neurological disorders, cardiovascular diseases, age-related diseases, and cancer - Covers a range of therapeutic approaches to target oxidative stress - Includes chapters on the application of novel drug delivery systems and diagnostic biosensors to oxidative stress - Features case studies illustrating the targeting of oxidative stress
Author: Ajay K. Banga
Publisher: CRC Press
ISBN: 1040060684
Category : Medical
Languages : en
Pages : 420
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Book Description
There are more than 500 biopharmaceuticals on the market, including more than 200 therapeutic proteins, making biologics the fastest growing sector in the biopharmaceutical market. These products include more than 40 monoclonal antibodies, for indications ranging from treatment or mitigation of various types of cancer to rheumatoid arthritis. The c
Author: Gyun Min Lee
Publisher: John Wiley & Sons
ISBN: 3527343342
Category : Science
Languages : en
Pages : 436
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Book Description
Offers a comprehensive overview of cell culture engineering, providing insight into cell engineering, systems biology approaches and processing technology In Cell Culture Engineering: Recombinant Protein Production, editors Gyun Min Lee and Helene Faustrup Kildegaard assemble top class authors to present expert coverage of topics such as: cell line development for therapeutic protein production; development of a transient gene expression upstream platform; and CHO synthetic biology. They provide readers with everything they need to know about enhancing product and bioprocess attributes using genome-scale models of CHO metabolism; omics data and mammalian systems biotechnology; perfusion culture; and much more. This all-new, up-to-date reference covers all of the important aspects of cell culture engineering, including cell engineering, system biology approaches, and processing technology. It describes the challenges in cell line development and cell engineering, e.g. via gene editing tools like CRISPR/Cas9 and with the aim to engineer glycosylation patterns. Furthermore, it gives an overview about synthetic biology approaches applied to cell culture engineering and elaborates the use of CHO cells as common cell line for protein production. In addition, the book discusses the most important aspects of production processes, including cell culture media, batch, fed-batch, and perfusion processes as well as process analytical technology, quality by design, and scale down models. -Covers key elements of cell culture engineering applied to the production of recombinant proteins for therapeutic use -Focuses on mammalian and animal cells to help highlight synthetic and systems biology approaches to cell culture engineering, exemplified by the widely used CHO cell line -Part of the renowned "Advanced Biotechnology" book series Cell Culture Engineering: Recombinant Protein Production will appeal to biotechnologists, bioengineers, life scientists, chemical engineers, and PhD students in the life sciences.
