Single Use Technology In Biopharmaceutical Manufacture
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Single Use Technology In Biopharmaceutical Manufacture
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Author : Regine Eibl
language : en
Publisher: John Wiley & Sons
Release Date : 2019-08-27
Single Use Technology In Biopharmaceutical Manufacture written by Regine Eibl and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-08-27 with Medical categories.
Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Disposable Bioreactors Ii
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Author : Dieter Eibl
language : en
Publisher: Springer
Release Date : 2013-12-17
Disposable Bioreactors Ii written by Dieter Eibl and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-12-17 with Science categories.
Dynamic Single-Use Bioreactors Used in Modern Liter- and m3- Scale Biotechnological Processes: Engineering Characteristics and Scaling Up, by Christian Löffelholz, Stephan C. Kaiser, Matthias Kraume, Regine Eibl , Dieter Eibl. Orbitally Shaken Single-Use Bioreactors, by Wolf Klöckner, Sylvia Diederichs, Jochen Büchs. Therapeutic Human Cells: Manufacture for Cell Therapy/Regenerative Medicine by Christian van den Bos, Robert Keefe, Carmen Schirmaier, Michael McCaman. Fast Single-Use VLP Vaccine Productions Based on Insect Cells and the Baculovirus Expression Vector System: Influenza as Case Study by Regine Eibl, Nina Steiger, Sabine Wellnitz, Tiago Vicente, Corinne John, Dieter Eibl. Microbial High Cell Density Fermentations in a Stirred Single-Use Bioreactor by Thomas Dreher, Bart Walcarius, Ute Husemann, Franziska Klingenberg, Christian Zahnow, Thorsten Adams, Davy de Wilde, Peter Casteels, Gerhard Greller. Quorus Bioreactor: A New Perfusion-Based Technology for Microbial Cultivation by Sheena J. Fraser, Christian Endres. Cultivation of Marine Microorganisms in Single-Use Systems by Friederike Hillig, Maciej Pilarek, Stefan Junne, Peter Neubauer. Flexible Biomanufacturing Processes that Address the Needs of the Future by Bernhard Diel, Christian Manzke, Thorsten Peuker. An Approach to Quality and Security of Supply for Single-Use Bioreactors by Magali Barbaroux, Susanne Gerighausen, Heiko Hackel. A Risk Analysis for Production Processes with Disposable Bioreactors by Tobias Merseburger, Ina Pahl, Daniel Müller, Markus Tanner.
Single Use Technology
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Author : Adriana G. Lopes
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2019-06-17
Single Use Technology written by Adriana G. Lopes and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-17 with Science categories.
Single-Use Technology (SUT) is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Having become readily available for all processing operations within the biopharmaceutical industry, SUT has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types.
Biopharmaceutical Production Technology
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2012-05-14
Biopharmaceutical Production Technology written by Ganapathy Subramanian and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-14 with Medical categories.
Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.
Continuous Processing In Pharmaceutical Manufacturing
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Author : Ganapathy Subramanian
language : en
Publisher: John Wiley & Sons
Release Date : 2015-02-09
Continuous Processing In Pharmaceutical Manufacturing written by Ganapathy Subramanian and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-02-09 with Medical categories.
With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.
Single Use Technology
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Author : Adriana G. Lopes
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2019-06-17
Single Use Technology written by Adriana G. Lopes and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-17 with Science categories.
Single-Use Technology (SUT) is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Having become readily available for all processing operations within the biopharmaceutical industry, SUT has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types.
Biopharmaceutical Processing
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Author : Gunter Jagschies
language : en
Publisher: Elsevier
Release Date : 2018-01-18
Biopharmaceutical Processing written by Gunter Jagschies and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-18 with Technology & Engineering categories.
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. Offers a comprehensive, go-to reference for daily work decisions Covers both upstream and downstream processes Includes case studies that emphasize financial outcomes Presents summaries, decision grids, graphs and overviews for quick reference
Continuous Manufacturing For The Modernization Of Pharmaceutical Production
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2019-04-05
Continuous Manufacturing For The Modernization Of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-05 with Medical categories.
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Bioprocessing Technology For Production Of Biopharmaceuticals And Bioproducts
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Author : Claire Komives
language : en
Publisher: John Wiley & Sons
Release Date : 2018-12-27
Bioprocessing Technology For Production Of Biopharmaceuticals And Bioproducts written by Claire Komives and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-12-27 with Science categories.
Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies
Process Architecture In Biomanufacturing Facility Design
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Author : Jeffery Odum
language : en
Publisher: John Wiley & Sons
Release Date : 2018-01-26
Process Architecture In Biomanufacturing Facility Design written by Jeffery Odum and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-26 with Science categories.
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.