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: Pitman, Arkadiy (Hemoglobin Oxygen Therapeutics LLC, Souderton, Pennsylvania, USA) Sverdlov, Oleksandr Pearce, L. Bruce Название: Mathematical and Statistical Skills in the Biopharmaceutical Industry ISBN: 036777951X ISBN-13(EAN): 9780367779511 Издательство: Taylor&Francis Рейтинг: Цена: 7961.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Discusses integral, pragmatic approach to solving problems relevant to biostatistics function in the pharmaceutical industry, emphasizes importance of logical, systematic thinking, clear problem formulation and answering research questions in selected terms.
Автор: Peace, Karl E. Название: Biopharmaceutical Sequential Statistical Applications ISBN: 0824786289 ISBN-13(EAN): 9780824786281 Издательство: Taylor&Francis Рейтинг: Цена: 42108.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Al-Gwaiz, M.A. Название: Biopharmaceutical Sequential Statistical Applications ISBN: 0367579987 ISBN-13(EAN): 9780367579982 Издательство: Taylor&Francis Рейтинг: Цена: 7808.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Focusing on group sequential procedures, summarizes the sequential statistical methods used in anticancer, antiviral, cardiovascular, and gastrointestinal drug research and screening. The clinical and preclinical applications are mainly presented as case studies, many of which form part of New Drug
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration.
Features:
Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product
Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing
Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement
It discusses the advantages of single-use process technologies and the qualification needs
Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs
The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
Автор: Edited By Maik W. Jornitz Название: Filtration and Purification in the Biopharmaceutical Industry ISBN: 1032338288 ISBN-13(EAN): 9781032338286 Издательство: Taylor&Francis Рейтинг: Цена: 7808.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of this field including the current methods, pro
Автор: Shukla, Abhinav A. Название: Process Scale Bioseparations for the Biopharmaceutical Industry ISBN: 0367577844 ISBN-13(EAN): 9780367577841 Издательство: Taylor&Francis Рейтинг: Цена: 7808.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Jagschies,Gunter Название: Biopharmaceutical Processing ISBN: 0081006233 ISBN-13(EAN): 9780081006238 Издательство: Elsevier Science Рейтинг: Цена: 46150.00 р. Наличие на складе: Нет в наличии.
Описание: Describes practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, this book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques.
