Single-Use Technology in Biopharmaceutical Manufacture

2019-08-27
 |  Medical
Single-Use Technology in Biopharmaceutical Manufacture

Author: Regine Eibl

Publisher: John Wiley & Sons

ISBN: 9781119477839

Category: Medical

Page: 368

View: 224

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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.

Single-Use Technology in Biopharmaceutical Manufacture

2019-07-24
 |  Medical
Single-Use Technology in Biopharmaceutical Manufacture

Author: Regine Eibl

Publisher: John Wiley & Sons

ISBN: 9781119477778

Category: Medical

Page: 368

View: 135

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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.

Process Architecture in Biomanufacturing Facility Design

2018-01-26
 |  Science
Process Architecture in Biomanufacturing Facility Design

Author: Jeffery Odum

Publisher: John Wiley & Sons

ISBN: 9781118833650

Category: Science

Page: 384

View: 634

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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.

Cell Culture Engineering and Technology

2021
 |  Biology
Cell Culture Engineering and Technology

Author: Ralf Pörtner

Publisher: Springer Nature

ISBN: 9783030798710

Category: Biology

Page: 552

View: 461

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This contributed volume is dedicated towards the progress achieved within the last years in all areas of Cell Culture Engineering and Technology. It comprises contributions of active researchers in the field of cell culture development for the production of recombinant proteins, cell line development, cell therapy and gene therapy, with consideration of media development, process scale-up, reactor design, monitoring and control and model-assisted strategies for process design. The knowledge and expertise of the authors cover disciplines like cell biology, engineering, biotechnology and biomedical sciences. This book is conceived for graduate students, postdoctoral fellows and researchers interested in the latest developments in Cell Engineering.

Biopharmaceutical Manufacturing

2021-09-07
 |  Science
Biopharmaceutical Manufacturing

Author: Gary Gilleskie

Publisher: Walter de Gruyter GmbH & Co KG

ISBN: 9783110616880

Category: Science

Page: 347

View: 601

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Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:

Disposable Bioreactors II

2013-12-17
 |  Science
Disposable Bioreactors II

Author: Dieter Eibl

Publisher: Springer

ISBN: 9783642451584

Category: Science

Page: 292

View: 809

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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

2019-06-17
 |  Science
Single-Use Technology

Author: Adriana G. Lopes

Publisher: Walter de Gruyter GmbH & Co KG

ISBN: 9783110640670

Category: Science

Page: 154

View: 363

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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.

Practical Guide to Single-use Technology

2016-08-31
 |  Science
Practical Guide to Single-use Technology

Author: Adriana G Lopes

Publisher: Smithers Rapra

ISBN: 9781910242049

Category: Science

Page: 178

View: 620

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Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It 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 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.Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents:An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems;SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP;Strategy for standardisation of single-use bag systems and assessment of extractables and leachables;Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams;Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; andQualification approach for different SUT types.With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT.

Current Developments in Biotechnology and Bioengineering

2016-09-17
 |  Science
Current Developments in Biotechnology and Bioengineering

Author: Christian Larroche

Publisher: Elsevier

ISBN: 9780444636744

Category: Science

Page: 850

View: 158

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Current Developments in Biotechnology and Bioengineering: Bioprocesses, Bioreactors and Controls provides extensive coverage of new developments, state-of-the-art technologies, and potential future trends, reviewing industrial biotechnology and bioengineering practices that facilitate and enhance the transition of processes from lab to plant scale, which is becoming increasingly important as such transitions continue to grow in frequency. Focusing on industrial bioprocesses, bioreactors for bioprocesses, and controls for bioprocesses, this title reviews industrial practice to identify bottlenecks and propose solutions, highlighting that the optimal control of a bioprocess involves not only maximization of product yield, but also taking into account parameters such as quality assurance and environmental aspects. Describes industrial bioprocesses based on the reaction media Lists the type of bioreactors used for a specific bioprocess/application Outlines the principles of control systems in various bioprocesses

Continuous Processing in Pharmaceutical Manufacturing

2015-02-09
 |  Medical
Continuous Processing in Pharmaceutical Manufacturing

Author: Ganapathy Subramanian

Publisher: John Wiley & Sons

ISBN: 9783527335954

Category: Medical

Page: 528

View: 369

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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.

Production of Biomass and Bioactive Compounds Using Bioreactor Technology

2014-09-30
 |  Science
Production of Biomass and Bioactive Compounds Using Bioreactor Technology

Author: Kee-Yoeup Paek

Publisher: Springer

ISBN: 9789401792233

Category: Science

Page: 709

View: 601

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The bioactive compounds of plants have world-wide applications in pharmaceutical, nutraceutical and food industry with a huge market. In this book, a group of active researchers have addressed on the most recent advances in plant cell and organ cultures for the production of biomass and bioactive compounds using bioreactors. Tremendous efforts have been made to commercialize the production of plant metabolites by employing plant cell and organ cultures in bioreactors. This book emphasizes on the fundamental topics like designing of bioreactors for plant cell and organ cultures, various types of bioreactors including stirred tank, airlift, photo-bioreactor, disposable bioreactor used for plant cell and organ cultures and the advantages and disadvantages of bioreactor cultures. Various strategies for biomass production and metabolite accumulation have been discussed in different plant systems including Korean/Chinese ginseng, Siberian ginseng, Indian ginseng, Echinacea, St. John’s wort, Noni, Chinese licorice, Caterpillar fungus and microalgae. Researches on the industrial application of plant cells and organs with future prospects as well as the biosafety of biomass produced in bioreactors are also described. The topics covered in this book, such as plant cell and organ cultures, hairy roots, bioreactors, bioprocess techniques, will be a valuable reference for plant biotechnologists, plant biologists, pharmacologists, pharmacists, food technologists, nutritionists, research investigators of healthcare industry, academia, faculty and students of biology and biomedical sciences. The multiple examples of large-scale applications of cell and organ cultures will be useful and significant to industrial transformation and real commercialization.