Approaches to the Conformational Analysis of Biopharmaceuticals, Lundblad, Roger L.
Автор: Vladimir I. Razinkov Название: High Throughput Formulation Development of Biopharmaceuticals ISBN: 1907568638 ISBN-13(EAN): 9781907568633 Издательство: Elsevier Science Рейтинг: Цена: 162820.00 T Наличие на складе: Поставка под заказ. Описание: High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary.
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1461469155 ISBN-13(EAN): 9781461469155 Издательство: Springer Рейтинг: Цена: 204970.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book highlights the challenges facing quality assurance/quality control (QA/QC) in today`s biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing.
Автор: Hefferon Название: Biopharmaceuticals in Plants ISBN: 1138114952 ISBN-13(EAN): 9781138114951 Издательство: Taylor&Francis Рейтинг: Цена: 81650.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Transgenic plants present enormous potential to become one of the most cost-effective and safe systems for large-scale production of proteins for industrial, pharmaceutical, veterinary, and agricultural uses. Over the past decade, much progress has been made with respect to the development of vaccines, antibodies, and other therapeutic proteins. Biopharmaceuticals in Plants: Toward the Next Century of Medicine provides a comprehensive survey of all major aspects of the development and production of plant-made biopharmaceuticals.
Accompanied by an exhaustive list of references to facilitate further study, this critical volume:
Describes the theory and practice of modern plant transformation techniques with respect to nuclear and plastic genomes
Outlines the steps involved in the generation of transgenic plants
Discusses the engineering of plant virus expression vectors for transient expression of vaccine proteins and other therapeutics in plant tissue
Addresses the significant role of glycosylation in the production of plant-made mammalian proteins
Investigates the basis of mucosal immunity using plant-based oral vaccines
Examines the scale-up of plant-derived vaccine and therapeutic proteins in entire crops or in large batch cell suspension cultures
Explores the development of clinical trials utilizing plant-derived biopharmaceutical proteins
Evaluates risks and biosafety concerns regarding plant-derived pharmaceuticals
The book concludes with a discussion of the future of plant-based vaccines and other therapeutic proteins with respect to commercial viability and as a tool to improve global public health. Far-reaching in its scope, this text is a baseline reference that students and researchers in a broad range of fields such as medicine, plant science, biotechnology, crop science, natural products chemistry, and engineering will consult regularly. It will also serve as a useful tool for individuals and companies seeking to invest in this dynamic area.
Автор: Lundblad Название: Approaches to the Conformational Analysis of Biopharmaceuticals ISBN: 1138114944 ISBN-13(EAN): 9781138114944 Издательство: Taylor&Francis Рейтинг: Цена: 76550.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "follow-on" biological products. While a wide variety of approaches to analysis exists, finding the most viable ones would be much easier with a consolidated reference that details the benefits and cost of each approach, with an emphasis on real results and real products.
Explores the Growing Role of Conformational Analysis in Comparing Generic Biopharmaceuticals
Approaches to the Conformational Analysis of Biopharmaceuticals gathers the most useful techniques and methods into a single volume, putting the greatest emphasis on those approaches that have proven the most fruitful. Rather than cover specific uses of techniques in detail, this book provides commercial biotechnologists and researchers with the information and references they need to make good choices about the technology they choose to use. With a large number of references that direct readers to primary source material, it includes studies drawn from the gamut of current literature, covering physical methods, such as differential scanning calorimetry, light scanning, and analytical ultracentrifugation. It also addresses chemical methods, such as hydrogen-deuterium exchange and trace labeling, along with infrared, ultraviolet, and Raman spectroscopy.
Written by Roger Lundblad, a true pioneer in protein science, this volume supplies the necessary information researchers need to access when deciding on the most cost-effective approach, including:
Comparability of biopharmaceuticals
Characterization of follow-on biologics
Quality attributes of protein biopharmaceuticals
Confrontational analysis of biopharmaceutical products
With a clear focus on relevant commercial biotechnology, this book belongs on the shelves of those serious researchers who are paving the way for the next generation of biopharmaceutical polymers.
Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field
Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature--and it's rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements.
Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future.
Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO--especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions
Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies
Includes many diagrams that clarify the design approach
Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
Автор: Phuc Van Pham Название: Stem Cell Drugs - A New Generation of Biopharmaceuticals ISBN: 3030075893 ISBN-13(EAN): 9783030075897 Издательство: Springer Рейтинг: Цена: 102480.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This invaluable resource discusses the current revolution in stem cell-based drugs and their potential use in clinical applications. Each chapter is contributed by a pre-eminent scientist in the field. An introductory section presents current stem cell drugs and stem cell-based products and a discussion of production, quality control, mechanisms, and efficacy. Following sections include discussions on stem cell-derived microvesicles based products, and derived exosomes based products.
Stem Cell Drugs - A New Generation of Biopharmaceuticals and the other books in the Stem Cells in Clinical Applications series are invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering. This groundbreaking volume is also essential reading for those researching or studying drug development or pharmaceutical science.
Автор: Behera, Basanta Название: Biopharmaceuticals ISBN: 0815347774 ISBN-13(EAN): 9780815347774 Издательство: Taylor&Francis Рейтинг: Цена: 183750.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book highlights how traditional microbial process technology has been upgraded for the production of biologic drugs, and evolution of manufacturing process to meet the global market demand with quality products under the guide lines of internally recognised regulatory bodies.
Автор: Pham Phuc Van Название: Stem Cell Drugs - A New Generation of Biopharmaceuticals ISBN: 3319993275 ISBN-13(EAN): 9783319993270 Издательство: Springer Рейтинг: Цена: 93160.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This invaluable resource discusses the current revolution in stem cell-based drugs and their potential use in clinical applications. Each chapter is contributed by a pre-eminent scientist in the field. An introductory section presents current stem cell drugs and stem cell-based products and a discussion of production, quality control, mechanisms, and efficacy. Following sections include discussions on stem cell-derived microvesicles based products, and derived exosomes based products.
Stem Cell Drugs - A New Generation of Biopharmaceuticals and the other books in the Stem Cells in Clinical Applications series are invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering. This groundbreaking volume is also essential reading for those researching or studying drug development or pharmaceutical science.
Автор: Staby Название: Preparative Chromatography for Separation of Proteins ISBN: 1119031109 ISBN-13(EAN): 9781119031109 Издательство: Wiley Рейтинг: Цена: 171020.00 T Наличие на складе: Поставка под заказ. Описание: Preparative Chromatography for Separation of Proteins addresses a wide range of the most current modeling techniques, strategies, and case studies of industrial separation of proteins and peptides to aid in the efficiency and efficacy of this broadly-used technique in the purification of biopharmaceuticals.
Complexity of Biologics CMC Regulation.- Biopharmaceutics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Biopharmaceutical Source Materials.- Manufacturing of Biopharmaceutical APIs.- Manufacturing of the Drug Product.- Complex Process-Related Impurity Profiles.- Product Characterization is a Journey.- Priceless Potency (Therapeutic Activity).- Quality Attributes of a Biopharmaceutical.- Designing the Stability Program.- The Art of Setting Specifications.- Demonstrating Product Comparability After Process Changes.- Invaluable CMC-Focused Meetings with Regulatory Authorities.
Автор: Rathore, Anurag S. Название: Process Validation in Manufacturing of Biopharmaceuticals ISBN: 1439850933 ISBN-13(EAN): 9781439850930 Издательство: Taylor&Francis Рейтинг: Цена: 204160.00 T Наличие на складе: Нет в наличии.
Автор: Liu Название: Biosimilars of Monoclonal Antibodies: A Practical Guide to Manufacturing, Preclinical, and Clinical Development ISBN: 1118662318 ISBN-13(EAN): 9781118662311 Издательство: Wiley Рейтинг: Цена: 171020.00 T Наличие на складе: Поставка под заказ. Описание: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
Казахстан, 010000 г. Астана, проспект Туран 43/5, НП2 (офис 2) ТОО "Логобук" Тел:+7 707 857-29-98 ,+7(7172) 65-23-70 www.logobook.kz
