Guidelines For Process Safety In Bioprocess Manufacturing Facilities

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Guidelines for Process Safety in Bioprocess Manufacturing Facilities

Author : CCPS (Center for Chemical Process Safety)
Publisher : John Wiley & Sons
ISBN 13 : 1118009002
Total Pages : 244 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Guidelines for Process Safety in Bioprocess Manufacturing Facilities by : CCPS (Center for Chemical Process Safety)

Download or read book Guidelines for Process Safety in Bioprocess Manufacturing Facilities written by CCPS (Center for Chemical Process Safety) and published by John Wiley & Sons. This book was released on 2011-12-28 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities.

Guidelines for Process Safety in Bioprocess Manufacturing Facilities

Author : CCPS (Center for Chemical Process Safety)
Publisher : John Wiley & Sons
ISBN 13 : 0470251492
Total Pages : 244 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Guidelines for Process Safety in Bioprocess Manufacturing Facilities by : CCPS (Center for Chemical Process Safety)

Download or read book Guidelines for Process Safety in Bioprocess Manufacturing Facilities written by CCPS (Center for Chemical Process Safety) and published by John Wiley & Sons. This book was released on 2010-11-23 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that promotes safe laboratory practices, procedures and use of containment equipment and facilities. Additionally, biomedical engineers, biologists, or other professionals without chemical engineering training or knowledge of inherently safe design are designing many of these facilities.

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.

Handbook of Industrial Chemistry and Biotechnology

Author : James A. Kent
Publisher : Springer Science & Business Media
ISBN 13 : 1461442591
Total Pages : 1560 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Handbook of Industrial Chemistry and Biotechnology by : James A. Kent

Download or read book Handbook of Industrial Chemistry and Biotechnology written by James A. Kent and published by Springer Science & Business Media. This book was released on 2013-01-13 with total page 1560 pages. Available in PDF, EPUB and Kindle. Book excerpt: Substantially revising and updating the classic reference in the field, this handbook offers a valuable overview and myriad details on current chemical processes, products, and practices. No other source offers as much data on the chemistry, engineering, economics, and infrastructure of the industry. The Handbook serves a spectrum of individuals, from those who are directly involved in the chemical industry to others in related industries and activities. It provides not only the underlying science and technology for important industry sectors, but also broad coverage of critical supporting topics. Industrial processes and products can be much enhanced through observing the tenets and applying the methodologies found in chapters on Green Engineering and Chemistry (specifically, biomass conversion), Practical Catalysis, and Environmental Measurements; as well as expanded treatment of Safety, chemistry plant security, and Emergency Preparedness. Understanding these factors allows them to be part of the total process and helps achieve optimum results in, for example, process development, review, and modification. Important topics in the energy field, namely nuclear, coal, natural gas, and petroleum, are covered in individual chapters. Other new chapters include energy conversion, energy storage, emerging nanoscience and technology. Updated sections include more material on biomass conversion, as well as three chapters covering biotechnology topics, namely, Industrial Biotechnology, Industrial Enzymes, and Industrial Production of Therapeutic Proteins.

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

Canadian Biosafety Standards and Guidelines for Facilities Handling Human and Terrestrial Animal Pathogens, Prions, and Biological Toxins

Download Canadian Biosafety Standards and Guidelines for Facilities Handling Human and Terrestrial Animal Pathogens, Prions, and Biological Toxins PDF Online Free

Author : Public Health Agency of Canada
Publisher : Canadian Museum of Civilization/Musee Canadien Des Civilisations
ISBN 13 :
Total Pages : 368 pages
Book Rating : 4.:/5 (319 download)

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Book Synopsis Canadian Biosafety Standards and Guidelines for Facilities Handling Human and Terrestrial Animal Pathogens, Prions, and Biological Toxins by : Public Health Agency of Canada

Download or read book Canadian Biosafety Standards and Guidelines for Facilities Handling Human and Terrestrial Animal Pathogens, Prions, and Biological Toxins written by Public Health Agency of Canada and published by Canadian Museum of Civilization/Musee Canadien Des Civilisations. This book was released on 2013 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: This first edition of the Canadian Biosafety Standards and Guidelines (CBSG) is a harmonized national standard for the handling and storing of human and terrestrial animal pathogens and toxins in Canada. The CBSG is the result of a joint initiative undertaken by the Public Health Agency of Canada (PHAC) and the Canadian Food Inspection Agency (CFIA) to update and harmonize existing Canadian biosafety standards and guidelines. It is intended to facilitate compliance by incorporating risk-, evidence- and, where possible, performance-based biosafety and biosecurity requirements, and by streamlining the requirements for handling or storing human or terrestrial animal pathogens and toxins into a single national reference document.

Guidelines for Inherently Safer Chemical Processes

Author : CCPS (Center for Chemical Process Safety)
Publisher : John Wiley & Sons
ISBN 13 : 1119529220
Total Pages : 388 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Guidelines for Inherently Safer Chemical Processes by : CCPS (Center for Chemical Process Safety)

Download or read book Guidelines for Inherently Safer Chemical Processes written by CCPS (Center for Chemical Process Safety) and published by John Wiley & Sons. This book was released on 2019-10-16 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the publication of the second edition several United States jurisdictions have mandated consideration of inherently safer design for certain facilities. Notable examples are the inherently safer technology (IST) review requirement in the New Jersey Toxic Chemical Prevention Act (TCPA), and the Inherently Safer Systems Analysis (ISSA) required by the Contra Costa County (California) Industrial Safety Ordinance. More recently, similar requirements have been proposed at the U.S. Federal level in the pending EPA Risk Management Plan (RMP) revisions. Since the concept of inherently safer design applies globally, with its origins in the United Kingdom, the book will apply globally. The new edition builds on the same philosophy as the first two editions, but further clarifies the concept with recent research, practitioner observations, added examples and industry methods, and discussions of security and regulatory issues. Inherently Safer Chemical Processes presents a holistic approach to making the development, manufacture, and use of chemicals safer. The main goal of this book is to help guide the future state of chemical process evolution by illustrating and emphasizing the merits of integrating inherently safer design process-related research, development, and design into a comprehensive process that balances safety, capital, and environmental concerns throughout the life cycle of the process. It discusses strategies of how to: substitute more benign chemicals at the development stage, minimize risk in the transportation of chemicals, use safer processing methods at the manufacturing stage, and decommission a manufacturing plant so that what is left behind does not endanger the public or environment.

Dealing with Aging Process Facilities and Infrastructure

Author : CCPS (Center for Chemical Process Safety)
Publisher : John Wiley & Sons
ISBN 13 : 1119430755
Total Pages : 200 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Dealing with Aging Process Facilities and Infrastructure by : CCPS (Center for Chemical Process Safety)

Download or read book Dealing with Aging Process Facilities and Infrastructure written by CCPS (Center for Chemical Process Safety) and published by John Wiley & Sons. This book was released on 2018-04-03 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines the concept of aging process facilities and infrastructure in high hazard industries and highlights options for dealing with the problem while addressing safety issues This book explores the many ways in which process facilities, equipment, and infrastructure might deteriorate upon continuous exposure to operating and climatic conditions. It covers the functional and physical failure modes for various categories of equipment and discusses the many warning signs of deterioration. Dealing with Aging Process Facilities and Infrastructure also explains how to deal with equipment that may not be safe to operate. The book describes a risk-based strategy in which plant leaders and supervisors can make more informed decisions on aging situations and then communicate them to upper management effectively. Additionally, it discusses the dismantling and safe removal of facilities that are approaching their intended lifecycle or have passed it altogether. Filled with numerous case studies featuring photographs to illustrate the positive and negative experiences of others who have dealt with aging facilities, Dealing with Aging Process Facilities and Infrastructure covers the causes of equipment failures due to aging and their consequences; plant management commitment and responsibility; inspection and maintenance practices for managing life cycle; specific aging asset integrity management practices; and more. Describes symptoms and causal mechanisms of aging in various categories of process equipment Presents key considerations for making informed risk-based decisions regarding the repair or replacement of aging process facilities and infrastructure Discusses practices for managing process facility and infrastructure life cycle Includes examples and case histories of failures related to aging Dealing with Aging Process Facilities and Infrastructure is an important book for industrial practitioners who are often faced with the challenge of managing process facilities and infrastructure as they approach the end of their useful lifecycle.

FDA Biotechnology Inspection Guide

Author : United States. Food and Drug Administration
Publisher :
ISBN 13 :
Total Pages : 62 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis FDA Biotechnology Inspection Guide by : United States. Food and Drug Administration

Download or read book FDA Biotechnology Inspection Guide written by United States. Food and Drug Administration and published by . This book was released on 1991 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Bioprocess Engineering

Author : Bjorn K. Lydersen
Publisher : John Wiley & Sons
ISBN 13 : 0471035440
Total Pages : 837 pages
Book Rating : 4.4/5 (71 download)

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Book Synopsis Bioprocess Engineering by : Bjorn K. Lydersen

Download or read book Bioprocess Engineering written by Bjorn K. Lydersen and published by John Wiley & Sons. This book was released on 1994-04-18 with total page 837 pages. Available in PDF, EPUB and Kindle. Book excerpt: Divided into four sections, the first and third reflect the fact that there are two types of equipment required in the plant--one in which the actual product is synthesized or processed such as the fermentor, centrifuge and chromatographic columns; and the other that supplies support for the facility or process including air conditioning, water and waste systems. Part two describes such components as pumps, filters and valves not limited to a certain type of equipment. Lastly, it covers planning and designing the entire facility along with requirements for containment and validation of the process.

Stem Cell Manufacturing

Author : Joaquim M.S. Cabral
Publisher : Elsevier
ISBN 13 : 0444632662
Total Pages : 342 pages
Book Rating : 4.4/5 (446 download)

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Book Synopsis Stem Cell Manufacturing by : Joaquim M.S. Cabral

Download or read book Stem Cell Manufacturing written by Joaquim M.S. Cabral and published by Elsevier. This book was released on 2016-07-24 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stem Cell Manufacturing discusses the required technologies that enable the transfer of the current laboratory-based practice of stem cell tissue culture to the clinic environment as therapeutics, while concurrently achieving control, reproducibility, automation, validation, and safety of the process and the product. The advent of stem cell research unveiled the therapeutic potential of stem cells and their derivatives and increased the awareness of the public and scientific community for the topic. The successful manufacturing of stem cells and their derivatives is expected to have a positive impact in the society since it will contribute to widen the offer of therapeutic solutions to the patients. Fully defined cellular products can be used to restore the structure and function of damaged tissues and organs and to develop stem cell-based cellular therapies for the treatment of cancer and hematological disorders, autoimmune and other inflammatory diseases and genetic disorders. - Presents the first 'Flowchart' of stem cell manufacturing enabling easy understanding of the various processes in a sequential and coherent manner - Covers all bioprocess technologies required for the transfer of the bench findings to the clinic including the process components: cell signals, bioreactors, modeling, automation, safety, etc. - Presents comprehensive coverage of a true multidisciplinary topic by bringing together specialists in their particular area - Provides the basics of the processes and identifies the issues to be resolved for large scale cell culture by the bioengineer - Addresses the critical need in bioprocessing for the successful delivery of stem cell technology to the market place by involving professional engineers in sections of the book

Continuous Manufacturing for the Modernization of Pharmaceutical Production

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309487811
Total Pages : 69 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Continuous Manufacturing for the Modernization of Pharmaceutical Production by : National Academies of Sciences, Engineering, and Medicine

Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Bioprocess Engineering Principles

Author : Pauline M. Doran
Publisher : Elsevier
ISBN 13 : 0080528120
Total Pages : 455 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Bioprocess Engineering Principles by : Pauline M. Doran

Download or read book Bioprocess Engineering Principles written by Pauline M. Doran and published by Elsevier. This book was released on 1995-04-03 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emergence and refinement of techniques in molecular biology has changed our perceptions of medicine, agriculture and environmental management. Scientific breakthroughs in gene expression, protein engineering and cell fusion are being translated by a strengthening biotechnology industry into revolutionary new products and services. Many a student has been enticed by the promise of biotechnology and the excitement of being near the cutting edge of scientific advancement. However, graduates trained in molecular biology and cell manipulation soon realise that these techniques are only part of the picture. Reaping the full benefits of biotechnology requires manufacturing capability involving the large-scale processing of biological material. Increasingly, biotechnologists are being employed by companies to work in co-operation with chemical engineers to achieve pragmatic commercial goals. For many years aspects of biochemistry and molecular genetics have been included in chemical engineering curricula, yet there has been little attempt until recently to teach aspects of engineering applicable to process design to biotechnologists.This textbook is the first to present the principles of bioprocess engineering in a way that is accessible to biological scientists. Other texts on bioprocess engineering currently available assume that the reader already has engineering training. On the other hand, chemical engineering textbooks do not consider examples from bioprocessing, and are written almost exclusively with the petroleum and chemical industries in mind. This publication explains process analysis from an engineering point of view, but refers exclusively to the treatment of biological systems. Over 170 problems and worked examples encompass a wide range of applications, including recombinant cells, plant and animal cell cultures, immobilised catalysts as well as traditional fermentation systems.* * First book to present the principles of bioprocess engineering in a way that is accessible to biological scientists* Explains process analysis from an engineering point of view, but uses worked examples relating to biological systems* Comprehensive, single-authored* 170 problems and worked examples encompass a wide range of applications, involving recombinant plant and animal cell cultures, immobilized catalysts, and traditional fermentation systems* 13 chapters, organized according to engineering sub-disciplines, are groupled in four sections - Introduction, Material and Energy Balances, Physical Processes, and Reactions and Reactors* Each chapter includes a set of problems and exercises for the student, key references, and a list of suggestions for further reading* Includes useful appendices, detailing conversion factors, physical and chemical property data, steam tables, mathematical rules, and a list of symbols used* Suitable for course adoption - follows closely curricula used on most bioprocessing and process biotechnology courses at senior undergraduate and graduate levels.

Biological Safety

Author : Dawn P. Wooley
Publisher : John Wiley & Sons
ISBN 13 : 155581963X
Total Pages : 300 pages
Book Rating : 4.5/5 (558 download)

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Book Synopsis Biological Safety by : Dawn P. Wooley

Download or read book Biological Safety written by Dawn P. Wooley and published by John Wiley & Sons. This book was released on 2020-07-02 with total page 300 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biological safety and biosecurity protocols are essential to the reputation and responsibility of every scientific institution, whether research, academic, or production. Every risk—no matter how small—must be considered, assessed, and properly mitigated. If the science isn't safe, it isn't good. Now in its fifth edition, Biological safety: Principles and Practices remains the most comprehensive biosafety reference. Led by editors Karen Byers and Dawn Wooley, a team of expert contributors have outlined the technical nuts and bolts of biosafety and biosecurity within these pages. This book presents the guiding principles of laboratory safety, including: the identification, assessment, and control of the broad variety of risks encountered in the lab; the production facility; and, the classroom. Specifically, Biological Safety covers protection and control elements—from biosafety level cabinets and personal protection systems to strategies and decontamination methods administrative concerns in biorisk management, including regulations, guidelines, and compliance various aspects of risk assessment covering bacterial pathogens, viral agents, mycotic agents, protozoa and helminths, gene transfer vectors, zooonotic agents, allergens, toxins, and molecular agents as well as decontamination, aerobiology, occupational medicine, and training A resource for biosafety professionals, instructors, and those who work with pathogenic agents in any capacity, Biological safety is also a critical reference for laboratory managers, and those responsible for managing biohazards in a range of settings, including basic and agricultural research, clinical laboratories, the vivarium, field study, insectories, and greenhouses.

Guideline on General Principles of Process Validation

Author :
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guideline on General Principles of Process Validation by :

Download or read book Guideline on General Principles of Process Validation written by and published by . This book was released on 1987 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Industrialization of Biology

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309316553
Total Pages : 158 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Industrialization of Biology by : National Research Council

Download or read book Industrialization of Biology written by National Research Council and published by National Academies Press. This book was released on 2015-06-29 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.

Preparing for Future Products of Biotechnology

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309452058
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.