Process Architecture In Biomanufacturing Facility Design

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Process Architecture in Biomanufacturing Facility Design

Author : Jeffery Odum
Publisher : John Wiley & Sons
ISBN 13 : 1118833651
Total Pages : 381 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Process Architecture in Biomanufacturing Facility Design by : Jeffery Odum

Download or read book Process Architecture in Biomanufacturing Facility Design written by Jeffery Odum and published by John Wiley & Sons. This book was released on 2018-01-26 with total page 381 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sterile Product Facility Design and Project Management

Author : Jeffrey N. Odum
Publisher : CRC Press
ISBN 13 : 1420025856
Total Pages : 391 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Sterile Product Facility Design and Project Management by : Jeffrey N. Odum

Download or read book Sterile Product Facility Design and Project Management written by Jeffrey N. Odum and published by CRC Press. This book was released on 2004-03-29 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provid

Biopharmaceutical Manufacturing

Author : Gary Gilleskie
Publisher : Walter de Gruyter GmbH & Co KG
ISBN 13 : 3110617013
Total Pages : 433 pages
Book Rating : 4.1/5 (16 download)

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Book Synopsis Biopharmaceutical Manufacturing by : Gary Gilleskie

Download or read book Biopharmaceutical Manufacturing written by Gary Gilleskie and published by Walter de Gruyter GmbH & Co KG. This book was released on 2021-09-07 with total page 433 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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:

Biopharmaceutical Processing

Author : Gunter Jagschies
Publisher : Elsevier
ISBN 13 : 0128125527
Total Pages : 1310 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Biopharmaceutical Processing by : Gunter Jagschies

Download or read book Biopharmaceutical Processing written by Gunter Jagschies and published by Elsevier. This book was released on 2018-01-18 with total page 1310 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 Biomanufacturing

Author : Ganapathy Subramanian
Publisher : John Wiley & Sons
ISBN 13 : 3527340637
Total Pages : 628 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Continuous Biomanufacturing by : Ganapathy Subramanian

Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-12-26 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.

Pharmaceutical Engineering Guides for New and Renovated Facilities

Author :
Publisher :
ISBN 13 : 9781931879095
Total Pages : 0 pages
Book Rating : 4.8/5 (79 download)

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Book Synopsis Pharmaceutical Engineering Guides for New and Renovated Facilities by :

Download or read book Pharmaceutical Engineering Guides for New and Renovated Facilities written by and published by . This book was released on 1996 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Cell Culture Engineering

Author : Wei-Shu Hu
Publisher : Springer
ISBN 13 : 3540340076
Total Pages : 179 pages
Book Rating : 4.5/5 (43 download)

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Book Synopsis Cell Culture Engineering by : Wei-Shu Hu

Download or read book Cell Culture Engineering written by Wei-Shu Hu and published by Springer. This book was released on 2006-08-16 with total page 179 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care. Many patients suffering with life-threatening diseases or chronic dysfunctions, which were medically untreatable not long ago, can attest to the wonder these drugs have achieved. Although the ?rst generation of p- tein therapeutics was produced in recombinant Escherichia coli, most recent products use mammalian cells as production hosts. Not long after the ?rst p- duction of recombinant proteins in E. coli, it was realized that the complex tasks of most post-translational modi?cations on proteins could only be ef?ciently carried out in mammalian cells. In the 1990s, we witnessed a rapid expansion of mammalian-cell-derived protein therapeutics, chie?y antibodies. In fact, it has been nearly a decade since the market value of mammalian-cell-derived protein therapeutics surpassed that of those produced from E. coli. A common characteristic of recent antibody products is the relatively large dose required for effective therapy, demanding larger quantities for the treatment of a given disease. This, coupled with the broadening repertoire of protein drugs, has rapidly expanded the quantity needed for clinical applications. The increasing demand for protein therapeutics has not been met exclusively by construction of new manufacturing plants and increasing total volume capacity. More - portantly the productivity of cell culture processes has been driven upward by an order of magnitude in the past decade.

Introduction to Biomanufacturing

Author : Northeast Biomanufacturing Center & Collaborative
Publisher :
ISBN 13 : 9781939070012
Total Pages : 510 pages
Book Rating : 4.0/5 (7 download)

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Book Synopsis Introduction to Biomanufacturing by : Northeast Biomanufacturing Center & Collaborative

Download or read book Introduction to Biomanufacturing written by Northeast Biomanufacturing Center & Collaborative and published by . This book was released on 2012-11-03 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today is a time of unparalleled excitement in the world of biopharmaceuticals. This book is a compendium of a tremendous body of knowledge, distilled into its most essential parts. Not only are there theoretical and conceptual ideas about biopharmaceutical manufacturing, but also content specific to skills and abilities. It serves as a well-paced guide for beginning learners as well as a cogent reference for seasoned biotechnology professionals alike. This book will help a new generation of students to become inspired and familiarize themselves with the theories, principles, and vernacular of biopharmaceutical production and all that it entails. A quick overview of contents include; Operational Excellence, Facilities, Metrology, Validation, Environmental Health & Safety (EHS), Quality Assurance, Microbiological Control, Quality Control Biochemistry, Upstream Processing, Downstream Processing, Process Development, and a Master Glossary.

Biotechnology Entrepreneurship

Author : Craig Shimasaki
Publisher : Academic Press
ISBN 13 : 0124047475
Total Pages : 489 pages
Book Rating : 4.1/5 (24 download)

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Book Synopsis Biotechnology Entrepreneurship by : Craig Shimasaki

Download or read book Biotechnology Entrepreneurship written by Craig Shimasaki and published by Academic Press. This book was released on 2014-04-08 with total page 489 pages. Available in PDF, EPUB and Kindle. Book excerpt: As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a ‘how-to’ for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars Case studies are interspersed throughout each chapter to support key concepts and best practices. Enhanced by use of numerous detailed graphics, tables and flow charts

The Vitra Campus

Author : Mateo Kries
Publisher :
ISBN 13 : 9783945852071
Total Pages : 204 pages
Book Rating : 4.8/5 (52 download)

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Book Synopsis The Vitra Campus by : Mateo Kries

Download or read book The Vitra Campus written by Mateo Kries and published by . This book was released on 2017-02-28 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the 1980s, the Vitra company has been erecting buildings in collaboration with some of the leading architects of the present day, including Zaha Hadid, Frank Gehry, Tadao Ando, SANAA, Álvaro Siza, Nicholas Grimshaw and Herzog & de Meuron. The Vitra Campus currently attracts over 350,000 visitors each year. While the renowned Vitra Design Museum presents alternating exhibitions, the newly built Schaudepot gives visitors an insight into parts of the museum's extensive collection. In addition, during their time on the Campus, visitors can take part in a guided tour of the architecture or a workshop, enjoy the view from the Vitra Slide Tower and afterwards slide down the 37-metre-long slide, experience furniture classics and new products from the Vitra Home Collection in the VitraHaus as well as savour the offers of the shops and cafés. With roughly 200 illustrations, The Vitra Campus offers an overview of Vitra architecture, its daily use, the evolution of the Campus and the biographies of the architects. It is ideally suited as a souvenir, as preparation for a visit, as a Campus guide or simply a fascinating read on some of the most significant architects of our time and their buildings. This new edition shows the new Campus buildings since 2014: the Álvaro-Siza-Promenade, Vitra Slide Tower by Carsten Höller, Vitra Schaudepot by Herzog & de Meuron and the project 24 Stops by the artist Tobias Rehberger.

Integrating Project Delivery

Author : Martin Fischer
Publisher : John Wiley & Sons
ISBN 13 : 0470587350
Total Pages : 480 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis Integrating Project Delivery by : Martin Fischer

Download or read book Integrating Project Delivery written by Martin Fischer and published by John Wiley & Sons. This book was released on 2017-03-27 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: A revolutionary, collaborative approach to design and construction project delivery Integrating Project Delivery is the first book-length discussion of IPD, the emergent project delivery method that draws on each stakeholder's unique knowledge to address problems before they occur. Written by authors with over a decade of research and practical experience, this book provides a primer on IPD for architects, designers, and students interested in this revolutionary approach to design and construction. With a focus on IPD in everyday operation, coverage includes a detailed explanation and analysis of IPD guidelines, and case studies that show how real companies are applying these guidelines on real-world projects. End-of-chapter questions help readers quickly review what they've learned, and the online forum allows them to share their insights and ideas with others who either have or are in the process of implementing IPD themselves. Integrating Project Delivery brings together the owners, architect, engineers, and contractors early in the development stage to ensure that problems are caught early, and to address them in a collaborative way. This book describes the parameters of this new, more efficient approach, with expert insight on real-world implementation. Compare traditional procurement with IPD Understand IPD guidelines, and how they're implemented Examine case studies that illustrate everyday applications Communicate with other IPD adherents in the online forum The IPD approach revolutionizes not only the workflow, but the relationships between the stakeholders – the atmosphere turns collaborative, and the team works together toward a shared goal instead of viewing one another as obstructions to progress. Integrated Project Delivery provides a deep exploration of this approach, with practical guidance and expert insight.

3D Printing in Medicine

Author : Frank J. Rybicki
Publisher : Springer
ISBN 13 : 3319619241
Total Pages : 139 pages
Book Rating : 4.3/5 (196 download)

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Book Synopsis 3D Printing in Medicine by : Frank J. Rybicki

Download or read book 3D Printing in Medicine written by Frank J. Rybicki and published by Springer. This book was released on 2017-09-27 with total page 139 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the fundamentals of three-dimensional (3D) printing, addresses the practical aspects of establishing a 3D printing service in a medical facility, and explains the enormous potential value of rendering images as 3D printed models capable of providing tactile feedback and tangible information on both anatomic and pathologic states. Individual chapters also focus on selected areas of applications for 3D printing, including musculoskeletal, craniomaxillofacial, cardiovascular, and neurosurgery applications. Challenges and opportunities related to training, materials and equipment, and guidelines are addressed, and the overall costs of a 3D printing lab and the balancing of these costs against clinical benefits are discussed. Radiologists, surgeons, and other physicians will find this book to be a rich source of information on the practicalities and expanding medical applications of 3D printing.

Development of Sustainable Bioprocesses

Author : Elmar Heinzle
Publisher : John Wiley & Sons
ISBN 13 : 9780470058909
Total Pages : 316 pages
Book Rating : 4.0/5 (589 download)

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Book Synopsis Development of Sustainable Bioprocesses by : Elmar Heinzle

Download or read book Development of Sustainable Bioprocesses written by Elmar Heinzle and published by John Wiley & Sons. This book was released on 2007-01-11 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioprocess technology involves the combination of living matter (whole organism or enzymes ) with nutrients under laboratory conditions to make a desired product within the pharmaceutical, food, cosmetics, biotechnology, fine chemicals and bulk chemicals sectors. Industry is under increasing pressure to develop new processes that are both environmentally friendly and cost-effective, and this can be achieved by taking a fresh look at process development; - namely by combining modern process modeling techniques with sustainability assessment methods. Development of Sustainable Bioprocesses: Modeling and Assessment describes methodologies and supporting case studies for the evolution and implementation of sustainable bioprocesses. Practical and industry-focused, the book begins with an introduction to the bioprocess industries and development procedures. Bioprocesses and bioproducts are then introduced, together with a description of the unit operations involved. Modeling procedures, a key feature of the book, are covered in chapter 3 prior to an overview of the key sustainability assessment methods in use (environmental, economic and societal). The second part of the book is devoted to case studies, which cover the development of bioprocesses in the pharmaceutical, food, fine chemicals, cosmetics and bulk chemicals industries. Some selected case studies include: citric acid, biopolymers, antibiotics, biopharmaceuticals. Supplementary material provides hands-on materials so that the techniques can be put into practice. These materials include a demo version of SuperPro Designer software (used in process engineering) and models of all featured case studies, excel sheets of assessment methods, Monte Carlo simulations and exercises. Previously available on CD-ROM, the supplementary material can now be accessed via http://booksupport.wiley.com by entering the author name, book title or isbn and clicking on the desired entry. This will then give a listing of all the content available for download. Please read any text files before downloading material.

Single-Use Technology in Biopharmaceutical Manufacture

Author : Regine Eibl
Publisher : John Wiley & Sons
ISBN 13 : 1119477786
Total Pages : 368 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl

Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-18 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Genetic Engineering & Biotechnology News

Author :
Publisher :
ISBN 13 :
Total Pages : 546 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis Genetic Engineering & Biotechnology News by :

Download or read book Genetic Engineering & Biotechnology News written by and published by . This book was released on 2009 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Regenerative Medicine and Stem Cell Biology

Author : Nagwa El-Badri
Publisher : Springer Nature
ISBN 13 : 3030553590
Total Pages : 374 pages
Book Rating : 4.0/5 (35 download)

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Book Synopsis Regenerative Medicine and Stem Cell Biology by : Nagwa El-Badri

Download or read book Regenerative Medicine and Stem Cell Biology written by Nagwa El-Badri and published by Springer Nature. This book was released on 2020-11-27 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook covers the basic aspects of stem cell research and applications in regenerative medicine. Each chapter includes a didactic component and a practical section. The book offers readers insights into: How to identify the basic concepts of stem cell biology and the molecular regulation of pluripotency and stem cell development. How to produce induced pluripotent stem cells (iPSCs) and the basics of transfection. The biology of adult stem cells, with particular emphasis on mesenchymal stromal cells and hematopoietic stem cells, and the basic mechanisms that regulate them. How cancer stem cells arise and metastasize, and their properties. How to develop the skills needed to isolate, differentiate and characterize adult stem The clinical significance of stem cell research and the potential problems that need to be overcome. Evaluating the use of stem cells for tissue engineering and therapies (the amniotic membrane) The applications of bio-nanotechnology in stem cell research. How epigenetic mechanisms, including various DNA modifications and histone dynamics, are involved in regulating the potentiality and differentiation of stem cells. The scientific methods, ethical considerations and implications of stem cell research.

Good Design Practices for GMP Pharmaceutical Facilities

Author : Terry Jacobs
Publisher : CRC Press
ISBN 13 : 1482258919
Total Pages : 535 pages
Book Rating : 4.4/5 (822 download)

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Book Synopsis Good Design Practices for GMP Pharmaceutical Facilities by : Terry Jacobs

Download or read book Good Design Practices for GMP Pharmaceutical Facilities written by Terry Jacobs and published by CRC Press. This book was released on 2016-08-19 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.