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| Author | : Vladimir Voynov |
| Publisher | : Humana Press |
| Total Pages | : 516 |
| Release | : 2016-05-01 |
| Genre | : Medical |
| ISBN | : 9781493959495 |
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 |
| Total Pages | : 400 |
| Release | : 2010-12-28 |
| Genre | : Medical |
| ISBN | : 1118043588 |
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 |
| Total Pages | : 481 |
| Release | : 2008-02-04 |
| Genre | : Science |
| ISBN | : 1592599222 |
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 |
| Total Pages | : 762 |
| Release | : 2017-12-04 |
| Genre | : Medical |
| ISBN | : 3527340866 |
Branchenführende Big-Pharma-Unternehmen und erstklassige Forscher präsentieren grundlegende Konzepte und Herausforderungen bei proteinbasierten Pharmazeutika. Beinhaltet auch eine Einführung in die aus Sicht der Arzneimittelentwicklung fünf wesentlichen Anwendungsbereiche.
| Author | : Joseph Bertolini |
| Publisher | : John Wiley & Sons |
| Total Pages | : 518 |
| Release | : 2012-12-26 |
| Genre | : Medical |
| ISBN | : 0470924314 |
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 | : Fahmida Khatoon Zahid Balouch |
| Publisher | : Springer Nature |
| Total Pages | : 178 |
| Release | : 2022-09-28 |
| Genre | : Psychology |
| ISBN | : 9811678979 |
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 | : Brian K Meyer |
| Publisher | : Elsevier |
| Total Pages | : 205 |
| Release | : 2012-01-02 |
| Genre | : Medical |
| ISBN | : 1908818107 |
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 |
| Total Pages | : 388 |
| Release | : 2001-10-26 |
| Genre | : Science |
| ISBN | : 9783527302703 |
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 | : Honghui Zhou |
| Publisher | : John Wiley & Sons |
| Total Pages | : 479 |
| Release | : 2015-10-26 |
| Genre | : Medical |
| ISBN | : 111889880X |
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 | : |
| Publisher | : Academic Press |
| Total Pages | : 410 |
| Release | : 2018-04-18 |
| Genre | : Science |
| ISBN | : 012814341X |
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
