Download or read book Therapeutic Proteins written by Vladimir Voynov and published by Humana Press. This book was released on 2016-05-01 with total page 516 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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."
Download or read book Aggregation of Therapeutic Proteins written by Wei Wang and published by John Wiley & Sons. This book was released on 2010-12-28 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Protein Therapeutics 2 Volume Set written by Tristan Vaughan and published by John Wiley & Sons. This book was released on 2017-12-04 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Therapeutic Proteins written by C. Mark Smales and published by Springer Science & Business Media. This book was released on 2008-02-04 with total page 481 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Production of Plasma Proteins for Therapeutic Use written by Joseph Bertolini and published by John Wiley & Sons. This book was released on 2012-12-26 with total page 518 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Novel Therapeutic Proteins written by Klaus Dembowsky and published by John Wiley & Sons. This book was released on 2001-10-26 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Therapeutic Protein Drug Products written by Brian K Meyer and published by Elsevier. This book was released on 2012-01-02 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Therapeutic Proteins written by Roland Kontermann and published by John Wiley & Sons. This book was released on 2012-01-31 with total page 373 pages. Available in PDF, EPUB and Kindle. Book excerpt: For this ready reference, the internationally renowned authority in the field, Roland Kontermann, has assembled a team of outstanding contributors from industry and academia to convey the worldwide knowledge on modifying therapeutic proteins in order to optimize their pharmacological potential. The result is a comprehensive work covering all approaches and aspects of the topic in one handy volume, making this indispensable reading for companies and research institutions working on the development of biopharmaceuticals.
Download or read book Therapeutic Proteins Against Human Diseases written by Fahmida Khatoon Zahid Balouch and published by Springer Nature. This book was released on 2022-09-28 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins written by Honghui Zhou and published by John Wiley & Sons. This book was released on 2015-10-26 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Therapeutic Peptides and Proteins written by Ajay K. Banga and published by CRC Press. This book was released on 2005-09-14 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact that it is still difficult to find up
Download or read book Therapeutic Proteins and Peptides written by and published by Academic Press. This book was released on 2018-04-18 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Co and Post Translational Modifications of Therapeutic Antibodies and Proteins written by T. Shantha Raju and published by John Wiley & Sons. This book was released on 2019-03-15 with total page 293 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Therapeutic Fc Fusion Proteins written by Steven M. Chamow and published by John Wiley & Sons. This book was released on 2013-12-18 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Oral Delivery of Therapeutic Peptides and Proteins written by Puneet Tyagi and published by Academic Press. This book was released on 2022-08-18 with total page 318 pages. Available in PDF, EPUB and Kindle. Book excerpt: Oral Delivery of Therapeutic Peptides and Proteins provides a complete overview of the journey scientists pursue to attain protein and peptide oral delivery. The book highlights the physiological challenges that must be accounted for in addition to overcoming protease inhibition and acid stability issues that are commonly mentioned in this area of research. Primary topics include formulation technologies being adopted for oral delivery of proteins and peptides, modification of actives to make them more suited for oral delivery, animal models and their shortcomings in assessing oral bioavailability, and in vitro models to simulate drug absorption and transport. Academics and industry researchers working in formulation development and researchers and advanced students in biotechnology and pharmacy will find this a useful resource. Demonstrates how proteins and peptides transport throughout the gastrointestinal tract and how to evaluate their biological fate when encapsulated into certain delivery systems Examines developing technologies to improve future oral bioavailability Includes the in vitro and preclinical techniques needed for development
Download or read book Protein Therapeutics written by Tristan Vaughan and published by John Wiley & Sons. This book was released on 2017-07-28 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Innovative Dosage Forms written by Yogeshwar Bachhav and published by John Wiley & Sons. This book was released on 2019-12-04 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.
