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: Alain Beck Название: Glycosylation Engineering of Biopharmaceuticals ISBN: 1493962663 ISBN-13(EAN): 9781493962662 Издательство: Springer Рейтинг: Цена: 16769.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Glyco-engineering is being developed as a method to control the composition of carbohydrates and to enhance the pharmacological properties of monoclonal antibodies (mAbs) and other proteins. In Glycosylation Engineering of Biopharmaceuticals: Methods and Protocols, experts in the field provide readers with production and characterization protocols of glycoproteins and glyco-engineered biopharmaceuticals with a focus on mAbs. The volume is divided in four complementary parts dealing with glyco-engineering of therapeutic proteins, glycoanalytics, glycoprotein complexes characterization, and PK/PD assays for therapeutic antibodies. Written in the highly successful Methods in Molecular Biology™ series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Glycosylation Engineering of Biopharmaceuticals: Methods and Protocols serves as an ideal guide for scientists striving to push forward the exciting field of engineered biopharmaceuticals.
Описание: In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed.
Автор: Beck Alain Название: Glycosylation Engineering of Biopharmaceuticals ISBN: 1627033262 ISBN-13(EAN): 9781627033268 Издательство: Springer Рейтинг: Цена: 23757.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This Methods in Molecular Biology(TM) book offers protocols for glycoproteins and glyco-engineered biopharmaceuticals with a focus on mAbs. Covers glyco-engineering of therapeutic proteins, glycoanalytics, glycoprotein complex characterization and PK/PD assays.
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: Marco Weert; Eva Horn M?ller Название: Immunogenicity of Biopharmaceuticals ISBN: 1441926089 ISBN-13(EAN): 9781441926081 Издательство: Springer Рейтинг: Цена: 26120.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals.
Автор: Behera, Basanta Название: Biopharmaceuticals ISBN: 0815347774 ISBN-13(EAN): 9780815347774 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. 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: Lundblad, Roger L. Название: Approaches to the Conformational Analysis of Biopharmaceuticals ISBN: 1439807809 ISBN-13(EAN): 9781439807804 Издательство: Taylor&Francis Рейтинг: Цена: 31390.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Hefferon Название: Biopharmaceuticals in Plants ISBN: 1138114952 ISBN-13(EAN): 9781138114951 Издательство: Taylor&Francis Рейтинг: Цена: 12248.00 р. 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: Pham Phuc Van Название: Stem Cell Drugs - A New Generation of Biopharmaceuticals ISBN: 3319993275 ISBN-13(EAN): 9783319993270 Издательство: Springer Рейтинг: Цена: 13974.00 р. 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: Rosales-Mendoza Название: Algae-Based Biopharmaceuticals ISBN: 3319812297 ISBN-13(EAN): 9783319812298 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Поставка под заказ.
Описание: This book constitutes a key reference on the use of algae in the biopharmaceuticals production field; providing an updated outlook on the achievements accomplished thus far and transmitting a prospective view for this biotechnological application. This book provides a detailed description of the technology as well as an updated outlook of the strides achieved thus far in the field of algae-based biopharmaceuticals. Algae constitute attractive expression hosts for the production of recombinant proteins with medical applications. Among the features that make them attractive candidates are: low cost, fast growth, wide biosynthetic capacity, and absence of human pathogens; which constitute substantial advantages with respect to bacterial and mammalian systems. First, the features of algae as convenient hosts for the production of BFs are analyzed in terms of production costs, biosynthetic capacity, and safety (Chapter 1). Second, the genetic engineering tools for algae-species are described. Nuclear and chloroplast-based expression approaches are analyzed and compared in terms of biosynthetic advantages, gene expression complexity, and DNA transfer approaches (Chapter 2). In the following sections, chapters 3 to 7, the state of the art on producing distinct types of BFs in algae species is presented. Although this book is mainly focused on BFs, considering that the production of compounds with health-promoting properties are achieved using genetically-engineered algae strains, chapter 8 deals with nutraceuticals. In the ninth chapter, the developments reported thus far are placed in perspective and challenges for the field are discussed. Critical future prospects comprise the following: optimizing large-scale production in bioreactors, implementing glycoengineering approaches, optimizing nuclear expression, exploring new approaches for oral delivery, and implementing regulatory frameworks to accomplish technology transfer and regulatory approval of algae-made BFs.
Описание: Master the design and operation of perfusion cell cultures with this authoritative reference. A perfect resource for groups active in the cell culture field, as well as graduate students in areas such as chemical engineering, biotechnology, chemistry and biology.
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