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.
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.
Membrane processes are increasingly used in pharmaceutical and biochemical engineering and biotechnology for concentration and purification, synthesis of molecules and drug delivery systems, and support for biochemical reactions. This book provides a state-of-the art overview of the classical membrane processes used in pharmaceutical and biochemical engineering and biotechnology, such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactors. It describes the general rules (principles, choice of configurations, membranes, parameters, etc.), recent developments (fouling control, increase permeate flux and selectivity, etc.), applications, and theoretical descriptions. Further, it presents emerging processes such as solvent resistant nanofiltration and membrane crystallization. - Presents classical membrane processes such as ultrafiltration, microfiltration, virus filtration, membrane chromatography, membrane emulsification, liquid membranes and membrane bioreactors - Presents emerging processes such as solvent resistant nanofiltration and membrane crystallization - Gives a complete description of each technique (principles, membrane materials and devices, fouling control, and theoretical description) - Contains numerous examples of applications - Includes a uniform notation throughout the book enhancing the presentation and understanding of the content - Includes extensive list of references
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.
Biochemical Engineering and Biotechnology, 2nd Edition, outlines the principles of biochemical processes and explains their use in the manufacturing of every day products. The author uses a diirect approach that should be very useful for students in following the concepts and practical applications. This book is unique in having many solved problems, case studies, examples and demonstrations of detailed experiments, with simple design equations and required calculations. - Covers major concepts of biochemical engineering and biotechnology, including applications in bioprocesses, fermentation technologies, enzymatic processes, and membrane separations, amongst others - Accessible to chemical engineering students who need to both learn, and apply, biological knowledge in engineering principals - Includes solved problems, examples, and demonstrations of detailed experiments with simple design equations and all required calculations - Offers many graphs that present actual experimental data, figures, and tables, along with explanations
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.
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.
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.
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.
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.
