Biotechnology And Safety Assessment

Biotechnology And Safety Assessment

Author: John A. Thomas

Publisher: CRC Press

Published: 1993-06-30

Total Pages: 296

ISBN-13: 9780781700801

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In this volume, experts from academe, industry, and public health institutes discuss the issues involved in toxicology evaluation, safety assessment, and regulation of biotechnology-derived drugs, foods, and plant products. Coverage includes recombinant DNA agents, monoclonal antibodies, recombinant hormones and other proteins, biotechnology-derived drug delivery systems, gene therapy for genetic diseases, and genetically engineered plants and plant products. Full consideration is given to key methodological issues in product development and testing, such as use of "in vitro" and "in vivo" toxicology tests, choice of animal models, and use of transgenic animal models and genetically altered species to study human diseases. The book includes an appendix describing available animal models and a glossary of terms, definitions, and acronyms.


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.


Safety Assessment of Transgenic Organisms in the Environment, Volume 8

Safety Assessment of Transgenic Organisms in the Environment, Volume 8

Author: Organisation for Economic Co-operation and Development

Publisher:

Published: 2018

Total Pages: 150

ISBN-13: 9789264303331

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Volume 8 of the Series contains the first biosafety 'consensus document' to deal with the biology of an insect, the mosquito Aedes aegypti. Issued by the OECD Working Group on the Harmonisation of Regulatory Oversight in Biotechnology, the science-based consensus documents collate information for use during the regulatory risk assessment of biotechnology products, i.e. transgenic organisms (plants, animals, micro-organisms) when intended for release in the environment. Ae. aegypti mosquito is vectoring yellow fever, dengue, Zika and Chikungunya diseases in tropical and sub-tropical regions worldwide. Biotechnological applications are developed to control the mosquito population and reduce virus transmission. The book provides information on Ae. aegypti taxonomy, morphology, life cycle, reproductive biology, genetics, ecology, interactions with other species and the environment. The mosquito effects on human and animal health, and the control strategies/specific programmes to limit its development are also summarised.


Food Safety of Proteins in Agricultural Biotechnology

Food Safety of Proteins in Agricultural Biotechnology

Author: Bruce G. Hammond

Publisher: CRC Press

Published: 2007-11-28

Total Pages: 318

ISBN-13: 1420005731

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With contributions from internationally recognized experts, Food Safety of Proteins in Agricultural Biotechnology comprehensively addresses how toxicology testing of proteins should be accomplished and how protein safety assessments should be carried out. Beginning with a background on protein biology, the book delineates the fundamental difference


Animal Biotechnology

Animal Biotechnology

Author: National Research Council

Publisher: National Academies Press

Published: 2002-11-29

Total Pages: 200

ISBN-13: 030916933X

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Genetic-based animal biotechnology has produced new food and pharmaceutical products and promises many more advances to benefit humankind. These exciting prospects are accompanied by considerable unease, however, about matters such as safety and ethics. This book identifies science-based and policy-related concerns about animal biotechnologyâ€"key issues that must be resolved before the new breakthroughs can reach their potential. The book includes a short history of the field and provides understandable definitions of terms like cloning. Looking at technologies on the near horizon, the authors discuss what we know and what we fear about their effectsâ€"the inadvertent release of dangerous microorganisms, the safety of products derived from biotechnology, the impact of genetically engineered animals on their environment. In addition to these concerns, the book explores animal welfare concerns, and our societal and institutional capacity to manage and regulate the technology and its products. This accessible volume will be important to everyone interested in the implications of the use of animal biotechnology.


Genetically Modified Food Sources

Genetically Modified Food Sources

Author: Victor Tutelyan

Publisher: Academic Press

Published: 2013-05-06

Total Pages: 363

ISBN-13: 0124058620

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Genetically Modified Food Sources reports detailed results of studies on the medical and biological safety of 14 species of genetically modified plant-derived organisms (GMOs). The authors focus on issues in GMO production and world output, specifically the basic legislative regulations of modern biotechnology in the Russian Federation. Also covered are international approaches to the medical and biological assessment of safety and control of the food produced from genetically modified organisms. A special chapter is devoted to the problem of informational coverage of novel biological technologies.Previously available only in a 2007 Russian-language edition published by the Russian Academy of Medical Sciences, this English translation has been completely revised and updated to include the latest developments in regulations and human and animal safety assessment practices.The book is addressed to a wide community of specialists working in the fields of food science, plant genetics, and food safety as well as medicine and biology. Students and postgraduates focusing on the problems of modern biotechnology and biological safety will find it a valuable guide to these topics. - Specific assessments of 14 species of genetically modified plant-derived organisms used for food supply - Addresses the safety assessment requirements to ensure consumer health - International coverage provides comparative insights into regulation development and application


Biotechnology And Safety Assessment

Biotechnology And Safety Assessment

Author: J A Thomas

Publisher: CRC Press

Published: 1998-11-17

Total Pages: 352

ISBN-13: 9781560327219

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This updated text explains how advances in mammalian and plant genetics contribute to better therapeutics agents and more wholesome foods. It addresses such topics as new pharmaceutical agents, agribiotechnology, safety evaluation of biotechnology-derived drugs, food safety, nutritional science, and regulatory and environmental aspects of genetically-modified organisms. New to this edition are chapters on biotherapeutics and herbicide-resistant crops. It should be of interest to biotechnology, toxicologists, pharmaceutical scientists, environmental scientists and agriculturists.


Safety in Industrial Microbiology and Biotechnology

Safety in Industrial Microbiology and Biotechnology

Author: C. H. Collins

Publisher: Elsevier

Published: 2015-09-03

Total Pages: 268

ISBN-13: 1483102149

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Safety in Industrial Microbiology and Biotechnology reviews the hazards involved in work with both naturally occurring and genetically-modified microorganisms. This text is divided into 12 chapters and begins with an overview of the laboratory- and industry-associated infection hazards. The subsequent chapters deal with the legal issues, containment, risk assessment, and pathogenicity testing of infection related to industrial microbiology and biotechnology. These topics are followed by discussions of the safety considerations in recombinant plasmid preparation, the safe handling of industrially-produced mammalian cells, and some genetic designs that can be applied to processes based on recombinant DNA microorganisms. Other chapters explore the design for safety in bioprocessing and the containment in the development and manufacture of recombinant DNA-derived products. The remaining chapters look into the monitoring and validation in biotechnological processes, as well as the occupational health implications of industrial biotechnology. This book will prove useful to biotechnologists, microbiologists, safety engineers, and researchers.