Biosafety in Industrial Biotechnology

Biosafety in Industrial Biotechnology

Author: P. Hambleton

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 317

ISBN-13: 9401113521

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As an industry, biotechnology may be likened to the Hymn Book, being both ancient and modern. Whereas activities such as baking, brewing, the fermenting of foods date from our earliest attempts to control and utilise the environment, the application of recombinant DNA technology is recognised as being at the forefront of novel industrial development. Perhaps because of its association with processing foodstuffs together with the benefits derived from applications in the early organic chemistry and pharmaceutical industries, biotechnology has been regarded as being inherently safe. Yet unlike other modern industries, such as chemical and nuclear, where regulation has followed from incidents or accidents, modern biotechnology has been subject to close scrutiny and regulation almost from its inception. The process of regulation itself is somewhat unusual in that it was initially self-imposed by the very scientists who developed the fundamental techniques of recombinant DNA technology. They recognised the signific ance of their development but were concerned of the effects on humans and the environment of uncontrolled application of the new, powerful technology. Concern about the possible consequences of genetic manipula tion has undoubtedly been the driving force behind the regulations that are now in place in many parts of the world and which are the subject of this book. Safety issues in the biotechnology industry can be categorised under three headings: worker, environmental and consumer (product) safety.


Safety in Cell and Tissue Culture

Safety in Cell and Tissue Culture

Author: G. Stacey

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 257

ISBN-13: 940114916X

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It is now more than half a century since animal cells first came into regular use in the laboratory. Instances of laboratory acquired infection and con tamination of therapeutic products, derived from the use of animal cell cultures are rare. The use of animal cells, in addition to an established role in the production of vaccines and therapeutic proteins, has many new medical applications including gene therapy, tissue engineering and cell therapy. Furthermore, C;ldvances in molecular and cell biology are enabling rapid development and application of these technologies and the development of new and more sensitive methods, such as nucleic acid amplification, for the characterisation of cells and the detection of adven titious agents. However, it is clear that there is no room for complacency in this field and the recent expansion in the use of animal cells in the manufacture of medical products and the development of new biological assays for diagnostic and pharmaco-toxicological screening, underlines the need for vigilance regarding the correct and safe use of animal cells as substrates. This book is therefore very timely and should prove to be a highly valuable text, finding a wider audience beyond those with respon sibility for laboratory safety. The book guides the reader from fundamental cell biology issues and the establishment of new in vitro methods, through testing and validation of cell lines and on to issues in the use of animal cells in manufacturing processes.


Putting Biotechnology to Work

Putting Biotechnology to Work

Author: National Research Council

Publisher: National Academies Press

Published: 1992-02-01

Total Pages: 133

ISBN-13: 0309047854

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The ability of the United States to sustain a dominant global position in biotechnology lies in maintaining its primacy in basic life-science research and developing a strong resource base for bioprocess engineering and bioproduct manufacturing. This book examines the status of bioprocessing and biotechnology in the United States; current bioprocess technology, products, and opportunities; and challenges of the future and what must be done to meet those challenges. It gives recommendations for action to provide suitable incentives to establish a national program in bioprocess-engineering research, development, education, and technology transfer.


Industrialization of Biology

Industrialization of Biology

Author: National Research Council

Publisher: National Academies Press

Published: 2015-06-29

Total Pages: 158

ISBN-13: 0309316553

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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.


Advances in Sustainable Biomaterials

Advances in Sustainable Biomaterials

Author: Ajay Kumar

Publisher: CRC Press

Published: 2024-10-28

Total Pages: 391

ISBN-13: 104015400X

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Sustainable biomaterials are used as substitutions for traditional materials in aerospace, automotive, civil, mechanical, environmental engineering, medical, and other industries. This book presents the current knowledge and recent developments on the characterization and application of sustainable biomaterials with biomanufacturing 4.0 techniques. The book also describes the unique properties of various classes of sustainable biomaterials, making them highly suitable for many industrial applications. Advances in Sustainable Biomaterials: Bioprocessing 4.0, Characterizations, and Applications presents key chapters on smart biopolymer composites production and processing methods and provides a wide range of applications in a variety of fields such as medical, food, agriculture, electronics, manufacturing, and chemical engineering. The book features the most recent and detailed information on advancements in biopolymer biomaterials and emphasizes synthesis, characterization, modeling, manufacturing, and testing strategies. Written to be used as a resource guide on biomaterials and innovations, undergraduate and postgraduate students studying manufacturing and materials science will find this book very useful in addition to those working in mechanical engineering, biomedical engineering, manufacturing of pharmaceuticals, biotechnology, and electronics engineering fields. The book can also be used as additional classroom reading for an advanced course on biomaterials modeling and optimization.


Preparing for Future Products of Biotechnology

Preparing for Future Products of Biotechnology

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2017-07-28

Total Pages: 231

ISBN-13: 0309452058

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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.


Bioprocessing of Viral Vaccines

Bioprocessing of Viral Vaccines

Author: Amine Kamen

Publisher: CRC Press

Published: 2022-09-06

Total Pages: 267

ISBN-13: 1000643050

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This book focuses on cell culture-produced viral vaccines to meet the needs of the rapidly expanding research and development in academia and industry in the field. This book introduces the basic principles of vaccination and the manufacturing of viral vaccines. Bioprocessing of Viral Vaccines, will provide an overview of the advanced strategies needed to respond to the challenges of new and established viral infection diseases. The first few chapters cover the basics of virology and immunology as essential concepts to understand the function and design of viral vaccines. The core of the content is dedicated to process development, including upstream processing and cell culture of viral vaccines, downstream processing, and extensive analytical technologies specific to viral vaccines. Advanced process analytical technologies (PAT) and Quality by Design (QbD) concepts are also introduced in the context of vaccine manufacturing. The case studies included cover inactivated, attenuated vaccines exemplified by influenza vaccines, sub-unit vaccines exemplified by Virus Like Particles (VLPs: HPV vaccines) and sub-unit vaccines (Flublock), vectored vaccines: adenoviruses and Vesicular stomatitis Virus (VSV) vectored vaccines, genomic vaccines (DNA and mRNA) vaccines as developed for COVID-19 response in particular and a review of COVID-19 vaccines approved or in advanced clinical trials. This book is aimed at graduate engineers and professionals in the fields of vaccinology, bioprocessing, and biomanufacturing of viral vaccines.