Integrated Cell And Bioprocess Engineering For Rapid And Intensive Continuous Production Of Biopharmaceuticals
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| Author | : Wei-Shu Hu |
| Publisher | : Springer |
| Total Pages | : 179 |
| Release | : 2006-08-16 |
| Genre | : Science |
| ISBN | : 3540340076 |
Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care. Many patients suffering with life-threatening diseases or chronic dysfunctions, which were medically untreatable not long ago, can attest to the wonder these drugs have achieved. Although the ?rst generation of p- tein therapeutics was produced in recombinant Escherichia coli, most recent products use mammalian cells as production hosts. Not long after the ?rst p- duction of recombinant proteins in E. coli, it was realized that the complex tasks of most post-translational modi?cations on proteins could only be ef?ciently carried out in mammalian cells. In the 1990s, we witnessed a rapid expansion of mammalian-cell-derived protein therapeutics, chie?y antibodies. In fact, it has been nearly a decade since the market value of mammalian-cell-derived protein therapeutics surpassed that of those produced from E. coli. A common characteristic of recent antibody products is the relatively large dose required for effective therapy, demanding larger quantities for the treatment of a given disease. This, coupled with the broadening repertoire of protein drugs, has rapidly expanded the quantity needed for clinical applications. The increasing demand for protein therapeutics has not been met exclusively by construction of new manufacturing plants and increasing total volume capacity. More - portantly the productivity of cell culture processes has been driven upward by an order of magnitude in the past decade.
| Author | : Ganapathy Subramanian |
| Publisher | : John Wiley & Sons |
| Total Pages | : 628 |
| Release | : 2017-12-26 |
| Genre | : Science |
| ISBN | : 3527340637 |
This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
| Author | : National Research Council |
| Publisher | : National Academies Press |
| Total Pages | : 133 |
| Release | : 1992-02-01 |
| Genre | : Science |
| ISBN | : 0309047854 |
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.
| Author | : Kamelia Boodhoo |
| Publisher | : John Wiley & Sons |
| Total Pages | : 400 |
| Release | : 2013-01-03 |
| Genre | : Science |
| ISBN | : 1118498534 |
The successful implementation of greener chemical processes relies not only on the development of more efficient catalysts for synthetic chemistry but also, and as importantly, on the development of reactor and separation technologies which can deliver enhanced processing performance in a safe, cost-effective and energy efficient manner. Process intensification has emerged as a promising field which can effectively tackle the challenges of significant process enhancement, whilst also offering the potential to diminish the environmental impact presented by the chemical industry. Following an introduction to process intensification and the principles of green chemistry, this book presents a number of intensified technologies which have been researched and developed, including case studies to illustrate their application to green chemical processes. Topics covered include: • Intensified reactor technologies: spinning disc reactors, microreactors, monolith reactors, oscillatory flow reactors, cavitational reactors • Combined reactor/separator systems: membrane reactors, reactive distillation, reactive extraction, reactive absorption • Membrane separations for green chemistry • Industry relevance of process intensification, including economics and environmental impact, opportunities for energy saving, and practical considerations for industrial implementation. Process Intensification for Green Chemistry is a valuable resource for practising engineers and chemists alike who are interested in applying intensified reactor and/or separator systems in a range of industries to achieve green chemistry principles.
| Author | : Wei-Shou Hu |
| Publisher | : CRC Press |
| Total Pages | : 466 |
| Release | : 2020-03-06 |
| Genre | : Science |
| ISBN | : 1498762867 |
This book is the culmination of three decades of accumulated experience in teaching biotechnology professionals. It distills the fundamental principles and essential knowledge of cell culture processes from across many different disciplines and presents them in a series of easy-to-follow, comprehensive chapters. Practicality, including technological advances and best practices, is emphasized. This second edition consists of major updates to all relevant topics contained within this work. The previous edition has been successfully used in training courses on cell culture bioprocessing over the past seven years. The format of the book is well-suited to fast-paced learning, such as is found in the intensive short course, since the key take-home messages are prominently highlighted in panels. The book is also well-suited to act as a reference guide for experienced industrial practitioners of mammalian cell cultivation for the production of biologics.
| Author | : Pauline M. Doran |
| Publisher | : Elsevier |
| Total Pages | : 455 |
| Release | : 1995-04-03 |
| Genre | : Science |
| ISBN | : 0080528120 |
The emergence and refinement of techniques in molecular biology has changed our perceptions of medicine, agriculture and environmental management. Scientific breakthroughs in gene expression, protein engineering and cell fusion are being translated by a strengthening biotechnology industry into revolutionary new products and services. Many a student has been enticed by the promise of biotechnology and the excitement of being near the cutting edge of scientific advancement. However, graduates trained in molecular biology and cell manipulation soon realise that these techniques are only part of the picture. Reaping the full benefits of biotechnology requires manufacturing capability involving the large-scale processing of biological material. Increasingly, biotechnologists are being employed by companies to work in co-operation with chemical engineers to achieve pragmatic commercial goals. For many years aspects of biochemistry and molecular genetics have been included in chemical engineering curricula, yet there has been little attempt until recently to teach aspects of engineering applicable to process design to biotechnologists.This textbook is the first to present the principles of bioprocess engineering in a way that is accessible to biological scientists. Other texts on bioprocess engineering currently available assume that the reader already has engineering training. On the other hand, chemical engineering textbooks do not consider examples from bioprocessing, and are written almost exclusively with the petroleum and chemical industries in mind. This publication explains process analysis from an engineering point of view, but refers exclusively to the treatment of biological systems. Over 170 problems and worked examples encompass a wide range of applications, including recombinant cells, plant and animal cell cultures, immobilised catalysts as well as traditional fermentation systems.* * First book to present the principles of bioprocess engineering in a way that is accessible to biological scientists* Explains process analysis from an engineering point of view, but uses worked examples relating to biological systems* Comprehensive, single-authored* 170 problems and worked examples encompass a wide range of applications, involving recombinant plant and animal cell cultures, immobilized catalysts, and traditional fermentation systems* 13 chapters, organized according to engineering sub-disciplines, are groupled in four sections - Introduction, Material and Energy Balances, Physical Processes, and Reactions and Reactors* Each chapter includes a set of problems and exercises for the student, key references, and a list of suggestions for further reading* Includes useful appendices, detailing conversion factors, physical and chemical property data, steam tables, mathematical rules, and a list of symbols used* Suitable for course adoption - follows closely curricula used on most bioprocessing and process biotechnology courses at senior undergraduate and graduate levels.
| Author | : National Academies of Sciences, Engineering, and Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 69 |
| Release | : 2019-04-05 |
| Genre | : Medical |
| ISBN | : 0309487811 |
On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
| Author | : National Research Council |
| Publisher | : National Academies Press |
| Total Pages | : 158 |
| Release | : 2015-06-29 |
| Genre | : Science |
| ISBN | : 0309316553 |
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.
| Author | : Cenk Undey |
| Publisher | : CRC Press |
| Total Pages | : 330 |
| Release | : 2011-12-07 |
| Genre | : Medical |
| ISBN | : 1439829454 |
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.
| Author | : Regine Eibl |
| Publisher | : John Wiley & Sons |
| Total Pages | : 367 |
| Release | : 2019-07-18 |
| Genre | : Medical |
| ISBN | : 1119477786 |
Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
