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Author: Vladimir Voynov
Publisher: Humana Press
Published: 2016-05-01
Total Pages: 516
ISBN-13: 9781493959495
DOWNLOAD EBOOK →Emphasizing the newest developments in the field, this volume presents detailed methodswith added emphasison therapeutic protein discovery. It features key tips and valuable implementation advice to ensure successful results."
Author: Wei Wang
Publisher: John Wiley & Sons
Published: 2010-12-28
Total Pages: 400
ISBN-13: 1118043588
DOWNLOAD EBOOK →This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.
Author: C. Mark Smales
Publisher: Springer Science & Business Media
Published: 2008-02-04
Total Pages: 481
ISBN-13: 1592599222
DOWNLOAD EBOOK →With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.
Author: Tristan Vaughan
Publisher: John Wiley & Sons
Published: 2017-12-04
Total Pages: 762
ISBN-13: 3527340866
DOWNLOAD EBOOK →In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then goes on to review other key aspects such as pharmacokinetics, safety and immunogenicity, manufacture, formulation and delivery. The handbook then takes a look at current key clinical applications for protein therapeutics, from respiratory and inflammation to oncology and immune-oncology, infectious diseases and rescue therapy. Finally, several exciting prospects for the future of protein therapeutics are highlighted and discussed.
Author: Joseph Bertolini
Publisher: John Wiley & Sons
Published: 2012-12-26
Total Pages: 518
ISBN-13: 0470924314
DOWNLOAD EBOOK →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: Brian K Meyer
Publisher: Elsevier
Published: 2012-01-02
Total Pages: 205
ISBN-13: 1908818107
DOWNLOAD EBOOK →Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulations A comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinic Discusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles
Author: Klaus Dembowsky
Publisher: John Wiley & Sons
Published: 2001-10-26
Total Pages: 388
ISBN-13: 9783527302703
DOWNLOAD EBOOK →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: Fahmida Khatoon Zahid Balouch
Publisher: Springer Nature
Published: 2022-09-28
Total Pages: 178
ISBN-13: 9811678979
DOWNLOAD EBOOK →This book compiles updated research about the implications of therapeutic proteins in various human diseases. The initial chapters of the book provide basic information on the therapeutic proteins and discuss techniques for their formulation, production, and analytic approaches for their characterization. The subsequent chapters shed light on therapies based on therapeutic proteins against metabolic disorders, neurological disorders, cancer, autoimmune disorders, and infectious diseases. Importantly, it presents the factors influencing the immunogenicity of therapeutic proteins, including, genetic factors, disease type, and origin of therapeutic protein, dose frequency, administration route, and treatment duration. The book also reviews the strategies for reducing immunogenicity associated with therapeutic proteins, including PEGylation, site specific mutagenesis, exon shuffling, and humanizing of monoclonal antibodies. Further, it presents strategies for improving the typical drawback associated with protein therapeutics including instability and limited penetration through biological barriers. This book covers various computational methods that are commonly used for designing therapeutic proteins and in silico method for predicting and improving in vivo efficacy of the therapeutic molecules. Lastly, the book highlights the recent advances in developing nanosized delivery systems to improve safety and efficacy of protein therapeutics. This book caters to students and researchers of medicinal chemistry, pharmaceutical sciences and therapeutics. It is also useful to clinicians working with therapeutic proteins.
Author: T. Shantha Raju
Publisher: John Wiley & Sons
Published: 2019-03-15
Total Pages: 293
ISBN-13: 1119053366
DOWNLOAD EBOOK →A Comprehensive Guide to Crucial Attributes of Therapeutic Proteins in Biological Pharmaceuticals With this book, Dr. Raju offers a valuable resource for professionals involved in research and development of biopharmaceutical and biosimilar drugs. This is a highly relevant work, as medical practitioners have increasingly turned to biopharmaceutical medicines in their search for safe and reliable treatments for complex diseases, while pharmaceutical researchers seek to expand the availability of biopharmaceuticals and create more affordable biosimilar alternatives. Readers receive a thorough overview of the major co-translational modifications (CTMs) and post-translational modifications (PTMs) of therapeutic proteins relevant to the development of biotherapeutics. The majority of chapters detail individual CTMs and PTMs that may affect the physicochemical, biochemical, biological, pharmacokinetic, immunological, toxicological etc. properties of proteins. In addition, readers are guided on the methodology necessary to analyze and characterize these modifications. Thus, readers gain not only an understanding of CTMs/PTMs, but also the ability to design and assess their own structure-function studies for experimental molecules. Specific features and topics include: Discussion of the research behind and expansion of biopharmaceuticals Twenty chapters detailing relevant CTMs and PTMs of proteins, such as glycosylation, oxidation, phosphorylation, methylation, proteolysis, etc. Each chapter offers an introduction and guide to the mechanisms and biological significance of an individual CTM or PTM, including practical guidance for experiment design and analysis An appendix of biologic pharmaceuticals currently on the market, along with an assessment of their PTMs and overall safety and efficacy This volume will prove a key reference on the shelves of industry and academic researchers involved in the study and development of biochemistry, molecular biology, biopharmaceuticals and proteins in medicine, particularly as biopharmaceuticals and biosimilars become ever more prominent tools in the field of healthcare.
Author: Steven M. Chamow
Publisher: John Wiley & Sons
Published: 2013-12-18
Total Pages: 345
ISBN-13: 3527675280
DOWNLOAD EBOOK →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.
