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Process Biotechnology
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Book Synopsis Statistics for Biotechnology Process Development by : Todd Coffey
Download or read book Statistics for Biotechnology Process Development written by Todd Coffey and published by CRC Press. This book was released on 2018-05-16 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.
Book Synopsis PAT Applied in Biopharmaceutical Process Development And Manufacturing by : Cenk Undey
Download or read book PAT Applied in Biopharmaceutical Process Development And Manufacturing written by Cenk Undey and published by CRC Press. This book was released on 2011-12-07 with total page 330 pages. Available in PDF, EPUB and Kindle. Book excerpt: As with all of pharmaceutical production, the regulatory environment for the production of therapeutics has been changing as a direct result of the US FDA-initiated Quality by Design (QbD) guidelines and corresponding activities of the International Committee for Harmonization (ICH). Given the rapid growth in the biopharmaceutical area and the complexity of the molecules, the optimum use of which are still being developed, there is a great need for flexible and proactive teams in order to satisfy the regulatory requirements during process development. Process Analytical Technologies (PAT) applied in biopharmaceutical process development and manufacturing have received significant attention in recent years as an enabler to the QbD paradigm. PAT Applied in Biopharmaceutical Process Development and Manufacturing covers technological advances in measurement sciences, data acquisition, monitoring, and control. Technical leaders present real-life case studies in areas including measuring and monitoring raw materials, cell culture, purification, and cleaning and lyophilization processes via advanced PAT. They also explore how data are collected and analyzed using advanced analytical techniques such as multivariate data analysis, monitoring, and control in real-time. Invaluable for experienced practitioners in PAT in biopharmaceuticals, this book is an excellent reference guide for regulatory officials and a vital training aid for students who need to learn the state of the art in this interdisciplinary and exciting area.
Book Synopsis Process Validation in Manufacturing of Biopharmaceuticals, Third Edition by : Anurag S. Rathore
Download or read book Process Validation in Manufacturing of Biopharmaceuticals, Third Edition written by Anurag S. Rathore and published by CRC Press. This book was released on 2012-05-09 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.
Book Synopsis Industrial Biotechnology by : Christoph Wittmann
Download or read book Industrial Biotechnology written by Christoph Wittmann and published by John Wiley & Sons. This book was released on 2017-03-06 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest volume in the Advanced Biotechnology series provides an overview of the main product classes and platform chemicals produced by biotechnological processes today, with applications in the food, healthcare and fine chemical industries. Alongside the production of drugs and flavors as well as amino acids, bio-based monomers and polymers and biofuels, basic insights are also given as to the biotechnological processes yielding such products and how large-scale production may be enabled and improved. Of interest to biotechnologists, bio and chemical engineers, as well as those working in the biotechnological, chemical, and food industries.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309465184 Total Pages :189 pages Book Rating :4.3/5 (94 download)
Book Synopsis Biodefense in the Age of Synthetic Biology by : National Academies of Sciences, Engineering, and Medicine
Download or read book Biodefense in the Age of Synthetic Biology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-05 with total page 189 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scientific advances over the past several decades have accelerated the ability to engineer existing organisms and to potentially create novel ones not found in nature. Synthetic biology, which collectively refers to concepts, approaches, and tools that enable the modification or creation of biological organisms, is being pursued overwhelmingly for beneficial purposes ranging from reducing the burden of disease to improving agricultural yields to remediating pollution. Although the contributions synthetic biology can make in these and other areas hold great promise, it is also possible to imagine malicious uses that could threaten U.S. citizens and military personnel. Making informed decisions about how to address such concerns requires a realistic assessment of the capabilities that could be misused. Biodefense in the Age of Synthetic Biology explores and envisions potential misuses of synthetic biology. This report develops a framework to guide an assessment of the security concerns related to advances in synthetic biology, assesses the levels of concern warranted for such advances, and identifies options that could help mitigate those concerns.
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)
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.
Book Synopsis Biotechnology and Food Process Engineering by : Henry G. Schwartzberg
Download or read book Biotechnology and Food Process Engineering written by Henry G. Schwartzberg and published by CRC Press. This book was released on 1990-05-23 with total page 514 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and its implication for the future, introduction to bio reactor engineering, bioreactor considerations for producing flavors and pigments from plant tissue culture, membrane bioreactors: enzime processes, food freeze concentration, supercritical fluid extraction, drying of foods, aseptic processing of foods, encapsulation and con trolled release do food components, extrusion of foods, developments in microwave food processing, robotics in food processing, integrationof computers in food processing.
Book Synopsis Applications of Biotechnology in Traditional Fermented Foods by : National Research Council
Download or read book Applications of Biotechnology in Traditional Fermented Foods written by National Research Council and published by National Academies Press. This book was released on 1992-02-01 with total page 208 pages. Available in PDF, EPUB and Kindle. Book excerpt: In developing countries, traditional fermentation serves many purposes. It can improve the taste of an otherwise bland food, enhance the digestibility of a food that is difficult to assimilate, preserve food from degradation by noxious organisms, and increase nutritional value through the synthesis of essential amino acids and vitamins. Although "fermented food" has a vaguely distasteful ring, bread, wine, cheese, and yogurt are all familiar fermented foods. Less familiar are gari, ogi, idli, ugba, and other relatively unstudied but important foods in some African and Asian countries. This book reports on current research to improve the safety and nutrition of these foods through an elucidation of the microorganisms and mechanisms involved in their production. Also included are recommendations for needed research.
Author :S. N. Mukhopadhyay Publisher :The Energy and Resources Institute (TERI) ISBN 13 :8179933075 Total Pages :622 pages Book Rating :4.1/5 (799 download)
Book Synopsis Process Biotechnology by : S. N. Mukhopadhyay
Download or read book Process Biotechnology written by S. N. Mukhopadhyay and published by The Energy and Resources Institute (TERI). This book was released on 2012-01-01 with total page 622 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rapid progress has been made in the discipline of biochemical engineering and biotechnology for bioprocess development during the last 50 years. Process Biotechnology: theory and practice has been written with the consideration that tutorial practice is as important as understanding the subject theoretically. This book is an introductory tutorial book involving multidisciplinary principles. Principal innovations that have been made in biosystem-related developments have been emphasized through tutorials in this book. The first few chapters cover theoretical aspects of biochemical and chemical engineering concerns in biotechnological advances in a concise manner. The rest have been dedicated to the tutorial aspects of this multidisciplinary subject. This book covers biological, ecological, chemical, and biochemical engineering topics related to the subject. It provides much needed theory-based solved numerical problems for practice in quantitative evaluation of various parameters relevant to process biotechnology. It will be useful for students who would like to further their careers as biotechnologists and can be used as a self-study text for practicing engineers, biotechnologists, microbiologists, and scientists involved in bioprocessing research and other related fields.
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 167 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.
Download or read book Algae Biotechnology written by Faizal Bux and published by Springer. This book was released on 2016-03-09 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the utilization of algae for the development of useful products and processes with the emphasis towards green technologies and processes, and the requirements to make these viable. Serving as a complete reference guide to the production of biofuels and other value added products from micro and macro algae, it covers various aspects of algal biotechnology from the basics to large scale cultivation, harvesting and processing for a variety of products. It is authored and edited by respected world experts in the field of algal biotechnology and provides the most up to date and cutting edge information on developments in the field. Over the past decade there has been substantial focus and related literature on the application of algal biomass for the generation of novel processes and products. ‘Algae Biotechnology: Products and Processes’ encompasses a holistic approach to critically evaluating developments in the field of algal biotechnology whilst taking into account recent advances and building on the body of knowledge. Aspects of the effects of harmful algae are also discussed, as well as the potential commercial application of algal biotechnology, the techno-economic feasibility of algal biodiesel production and the use of genetic and metabolic engineering for the improvement of yield. Other bioenergy sources such as alcohol fuels, aviation fuels, biohydrogen and biogas are also covered. This book is intended for postgraduates and researchers working in the biofuels and algal industry; it constitutes ideal reference material for both early stage and established researchers.
Book Synopsis Process Engineering in Biotechnology by : A. T. Jackson
Download or read book Process Engineering in Biotechnology written by A. T. Jackson and published by . This book was released on 1991 with total page 168 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Downstream Process Technology: A New Horizon In Biotechnology by : Krishna Kant Prasad
Download or read book Downstream Process Technology: A New Horizon In Biotechnology written by Krishna Kant Prasad and published by PHI Learning Pvt. Ltd.. This book was released on 2010-01-30 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today, biochemical process industry demands fast and economic processes for the partitioning and purification of biomolecules that give high yield and high purity of the product. An integral and cost intensive part of these processes is associated with downstream processing for product isolation and purification. The aim of this comprehensive text is to provide an insightful overview of the whole aspects of downstream processing for biochemical product recovery. Intended for undergraduate and postgraduate students of biotechnology and chemical engineering, this self-contained text includes the chapters based on the recent developments in the industry and academics. It covers the importance of the downstream processing in terms of its relevancy to modern days ever-changing consumer needs, process design criteria relevance to set objectives, and physicochemical factors that help to formulate the strategy to develop a configuration among the raw material, methodology and instruments. This overview is followed by different downstream processing steps. The text concludes with the discussion on stabilization of the product to improve the shelf life of the product. Key Features Includes detailed biological, mathematical, chemical and physical aspects of downstream processing. Distinguishes downstream processing from analytical bioseparation. Contains numerous illustrations and solved problems.
Book Synopsis Process Synthesis for Fuel Ethanol Production by : C.A. Cardona
Download or read book Process Synthesis for Fuel Ethanol Production written by C.A. Cardona and published by CRC Press. This book was released on 2009-12-03 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process engineering can potentially provide the means to develop economically viable and environmentally friendly technologies for the production of fuel ethanol. Focusing on a key tool of process engineering, Process Synthesis for Fuel Ethanol Production is a comprehensive guide to the design and analysis of the most advanced technologies for fuel
Book Synopsis Process Monitoring and Quality by Design for Biotechnology Products by : Neslihan Delacruz
Download or read book Process Monitoring and Quality by Design for Biotechnology Products written by Neslihan Delacruz and published by Morgan & Claypool Publishers. This book was released on 2010-12-31 with total page 39 pages. Available in PDF, EPUB and Kindle. Book excerpt: Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that allows the operating ranges and the acceptance criteria to be established based on the impact on product quality attributes. During manufacturing, process monitoring becomes part of a continuous verification effort and statistical control limits can be used to signal potential trends or drifts in the process. Single manufacturing batches that are aberrant are readily identified. The melding of scientific understanding, information systems architecture, instrumentation, software, and personnel training provides a large return on investment by ensuring that the manufacturing process produces a consistent pharmaceutical product that meets acceptable release standards for human use.
Book Synopsis Career Opportunities in Biotechnology and Drug Development by : Toby Freedman
Download or read book Career Opportunities in Biotechnology and Drug Development written by Toby Freedman and published by CSHL Press. This book was released on 2008 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential guide for students in the life sciences, established researchers, and career counselors, this resource features discussions of job security, future trends, and potential career paths. Even those already working in the industry will find helpful information on how to take advantage of opportunities within their own companies and elsewhere.
Book Synopsis Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation by : Kenneth E. Avis
Download or read book Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation written by Kenneth E. Avis and published by CRC Press. This book was released on 2020-08-13 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this unique book, experts describe practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, the book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques. Large-scale chromatography for the purification of biomolecules in manufacturing and lyophilization of protein pharmaceuticals are discussed. Includes a case study on blow-fill-seal processing technology and a chapter on economic and cost factors for bioprocess engineering.
