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Today is a time of unparalleled excitement in the world of biopharmaceuticals. This book is a compendium of a tremendous body of knowledge, distilled into its most essential parts. Not only are there theoretical and conceptual ideas about biopharmaceutical manufacturing, but also content specific to skills and abilities. It serves as a well-paced guide for beginning learners as well as a cogent reference for seasoned biotechnology professionals alike. This book will help a new generation of students to become inspired and familiarize themselves with the theories, principles, and vernacular of biopharmaceutical production and all that it entails. A quick overview of contents include; Operational Excellence, Facilities, Metrology, Validation, Environmental Health & Safety (EHS), Quality Assurance, Microbiological Control, Quality Control Biochemistry, Upstream Processing, Downstream Processing, Process Development, and a Master Glossary.
With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. - A focus on the issues associated with the application of lean principles to biomanufacturing - Practical examples of factors which can affect biopharmaceutical processes - Coverage of key factors which require integration to run an efficient biopharmaceutical process
Biotechnology for Beginners, Third Edition presents the latest developments in the evolving field of biotechnology which has grown to such an extent over the past few years that increasing numbers of professional's work in areas that are directly impacted by the science. This book offers an exciting and colorful overview of biotechnology for professionals and students in a wide array of the life sciences, including genetics, immunology, biochemistry, agronomy and animal science. This book will also appeals to lay readers who do not have a scientific background but are interested in an entertaining and informative introduction to the key aspects of biotechnology. Authors Renneberg and Loroch discuss the opportunities and risks of individual technologies and provide historical data in easy-to-reference boxes, highlighting key topics. The book covers all major aspects of the field, from food biotechnology to enzymes, genetic engineering, viruses, antibodies, and vaccines, to environmental biotechnology, transgenic animals, analytical biotechnology, and the human genome. - Covers the whole of biotechnology - Presents an extremely accessible style, including lavish and humorous illustrations throughout - Includes new chapters on CRISPR cas-9, COVID-19, the biotechnology of cancer, and more
This book is a short introduction to the engineering principles of harnessing the vast potential of microorganisms, and animal and plant cells in making biochemical products. It was written for scientists who have no background in engineering, and for engineers with minimal background in biology. The overall subject dealt with is process. But the coverage goes beyond the process of biomanufacturing in the bioreactor, and extends to the factory of cell’s biosynthetic machinery. Starting with an overview of biotechnology and organism, engineers are eased into biochemical reactions and life scientists are exposed to the technology of production using cells. Subsequent chapters allow engineers to be acquainted with biochemical pathways, while life scientist learn about stoichiometric and kinetic principles of reactions and cell growth. This leads to the coverage of reactors, oxygen transfer and scale up. Following three chapters on biomanufacturing of current and future importance, i.e. cell culture, stem cells and synthetic biology, the topic switches to product purification, first with a conceptual coverage of operations used in bioseparation, and then a more detailed analysis to provide a conceptual understanding of chromatography, the modern workhorse of bioseparation. Drawing on principles from engineering and life sciences, this book is for practitioners in biotechnology and bioengineering. The author has used the book for a course for advanced students in both engineering and life sciences. To this end, problems are provided at the end of each chapter.
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
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.
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.
3D Printing in Medicine and Surgery: Applications in Healthcare is an advanced book on surgical and enhanced medical applications that can be achieved with 3D printing. It is an essential handbook for medical practitioners, giving access to a range of practical methods, while also focusing on applied knowledge. This comprehensive resource features practical experiments and processes for preparing 3D printable materials. Early chapters cover foundational knowledge and background reading, while later chapters discuss and review the current technologies used to engineer specific tissue types, experiments and methods, medical approaches and the challenges that lie ahead for future research. The book is an indispensable reference guide to the various methods used by current medical practitioners working at the forefront of 3D printing applications in medicine. - Provides a detailed introduction and narrative on how 3-D printing can be used towards developing future medicine-based therapies - Covers up-to-date methods across a range of application areas for the first time in book form - Presents the only book on all current areas of 3D printing in medicine that is catered to a medical rather than engineering audience
This report surveys opportunities for future Army applications in biotechnology, including sensors, electronics and computers, materials, logistics, and medical therapeutics, by matching commercial trends and developments with enduring Army requirements. Several biotechnology areas are identified as important for the Army to exploit, either by direct funding of research or by indirect influence of commercial sources, to achieve significant gains in combat effectiveness before 2025.
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.