Автор: Rathore, Anurag S. Название: Process Validation in Manufacturing of Biopharmaceuticals ISBN: 1439850933 ISBN-13(EAN): 9781439850930 Издательство: Taylor&Francis Рейтинг: Цена: 30624.00 р. 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.
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.
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.
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: 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.
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1493943995 ISBN-13(EAN): 9781493943999 Издательство: Springer Рейтинг: Цена: 22359.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: In its new edition, this book reviews the challenges facing quality assurance and control (QA/QC) in today`s biopharmaceutical environment, putting into perspective the need for a graded approach to QA/QC from early clinical trials through market approval.
Автор: Geigert, John Название: Challenge of cmc regulatory compliance for biopharmaceuticals ISBN: 1461469155 ISBN-13(EAN): 9781461469155 Издательство: Springer Рейтинг: Цена: 30745.00 р. 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.
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: 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.
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.
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.
ООО "Логосфера " Тел:+7(495) 980-12-10 www.logobook.ru
