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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.
This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.
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. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography
This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization of process related protein drug impurities/degradants, metabolites, higher order structures of protein therapeutics. Both general practitioners in pharmaceutical research and specialists in analytical sciences will benefit from this book that details step-by-step approaches and new strategies to solve challenging problems related to protein therapeutics research and development.
The Biology and Therapeutic Application of Mesenchymal Cells comprehensively describes the cellular and molecular biology of mesenchymal stem cells and mesenchymal stromal cells, describing their therapeutic potential in a wide variety of preclinical models of human diseases and their mechanism of action in these preclinical models. Chapters also discuss the current status of the use of mesenchymal stem and stromal cells in clinical trials in a wide range of human diseases and disorders, for many of which there are limited, or no other, therapeutic avenues. Provides coverage on both the biology of mesenchymal stem cells and stromal cells, and their therapeutic applications Describes the therapeutic potential of mesenchymal stem and stromal cells in a wide variety of preclinical models of human diseases and their mechanism of action in these preclinical models Discusses the current status of mesenchymal stem and stromal cells in clinical trials in a wide range of human diseases and disorders, for many of which there are limited, or no other, therapeutic avenues Written and edited by leaders in the field The Biology and Therapeutic Application of Mesenchymal Cells is an invaluable resource for those studying stem cells, cell biology, genetics, gene or cell therapy, or regenerative medicine.
PEGylation technology and key applications are introduced by this topical volume. Basic physical and chemical properties of PEG as basis for altering/improving in vivo behaviour of PEG-conjugates such as increased stability, improved PK/PD, and decreased immunogenicity, are discussed. Furthermore, chemical and enzymatic strategies for the coupling and the conjugate characterization are reported. Following chapters describe approved and marketed PEG-proteins and PEG-oligonucleotides as well as conjugates in various stages of clinical development.
Proteins Biochemistry and Biotechnology 2e is a definitive source of information for all those interested in protein science, and particularly the commercial production and isolation of specific proteins, and their subsequent utilization for applied purposes in industry and medicine. Fully updated throughout with new or fundamentally revised sections on proteomics as, bioinformatics, protein glycosylation and engineering, well as sections detailing advances in upstream processing and newer protein applications such as enzyme-based biofuel production this new edition has an increased focus on biochemistry to ensure the balance between biochemisty and biotechnology, enhanced with numerous case studies. This second edition is an invaluable text for undergraduates of biochemistry and biotechnology but will also be relevant to students of microbiology, molecular biology, bioinformatics and any branch of the biomedical sciences who require a broad overview of the various medical, diagnostic and industrial uses of proteins. • Provides a comprehensive overview of all aspects of protein biochemisty and protein biotechnology • Includes numerous case studies • Increased focus on protein biochemistry to ensure balance between biochemisty and biotechnology • Includes new section focusing on proteomics as well as sections detailing protein function and enzyme-based biofuel production "With the potential of a standard reference source on the topic, any molecular biotechnologist will profit greatly from having this excellent book. " (Engineering in Life Sciences, 2004; Vol 5; No. 5) “Few texts would be considered competitors, and none compare favorably." (Biochemistry and Molecular Education, July/August 2002) "...The book is well written, making it informative and easy to read..." (The Biochemist, June 2002)
Systematically addressing the key steps and challenges along the biopharmaceutical production process, this two volume handbook provides key knowledge for medium to large scale producers of biopharmaceuticals. The volumes are divided into six major parts, on upstream technologies, protein recovery, process development, analytical technologies, quality control, and an outlook section that addresses new and emerging technologies, such as single-use processes and integrated process design. With contributions by some 40 experts from academia, as well as small and large biopharmaceutical companies, this unique handbook is full of valuable first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.
Encyclopedic, definitive, and state-of-the-art in the field of vascular disease and its medical, surgical, and interventional management, Rutherford's Vascular Surgery and Endovascular Therapy offers authoritative guidance from the most respected and innovative global thought leaders and clinical and basic science experts of our time. The thoroughly revised 10th Edition, published in association with the Society for Vascular Surgery and authored by multidisciplinary and international contributors, is an outstanding reference for vascular surgeons, vascular medicine specialists, interventional radiologists and cardiologists, and their trainees who depend upon Rutherford's in their practice. Under the expert editorial guidance of Drs. Anton N. Sidawy and Bruce A. Perler, it is quite simply the most complete and most reliable resource available on the art and science of circulatory diseases. - Incorporates fundamental vascular biology, diagnostic techniques, and decision making as well as medical, endovascular, and surgical treatment of vascular disease. - Features numerous concise and comprehensive diagnostic and therapeutic algorithms vital to patient evaluation and management. - Covers all vascular imaging techniques, offering a non-invasive evaluation of both the morphology and hemodynamics of the vascular system. - Employs a full-color layout, images and online videos, so readers can view clinical and physical findings and operative techniques more vividly. - Contains fully updated and more concise chapters with a focused format and summary for each that provides a quick access to key information—ideal for consultation as well as daily practice. - Includes expanded coverage of the business of vascular surgery, including a new section on the use of technology platforms and social media, and new chapters on telemedicine, the development and operation of outpatient dialysis centers and multispecialty cardiovascular centers, vascular information on the internet, and much more. - Provides new content on key topics such as endovascular treatment of complex aortic disease, acute vascular occlusion in the pediatric population, outpatient vascular care, and anatomic surgical exposures for open surgical reconstructions. - Enhanced eBook version included with purchase. Your enhanced eBook allows you to access all of the text, figures, and references from the book on a variety of devices.
Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today's industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical's developability and the technical decision-making process needed when dealing with biophysical characterization data. - Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development - Highlights the capabilities and limitations of each technique - Discusses the underlining science of each tool - Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools - Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry