Thus, tracking cell ages provides avenues to design new systems that may be able to filter such aging cell populations out, thereby potentially increasing the overall productivity of the system. The groundwork for this is providing solution strategies for population balance models including numerical approaches as well as direct analytical solutions. Both approaches are analyzed here in great depth.
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.
Describes the state-of-the-art techniques and methods involved in the design, operation, preparation and containment of bioreactor systems, taking into account the interrelated effects of variables associated with both upstream and downstream stages of the design process. The importance of the initial steps in the development of a bioprocess, such as strain and media selection, that have an overwhelming influence on all further operations, is emphasized.;This work is intended for biochemical, chemical and bioprocess engineers; biotechnologists; industrial biochemists; micro- and molecular biologists; food scientists; and upper-level undergraduate and graduate students in these disciplines.
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.
The completion of the Human Genome Project and the rapid progress in cell bi- ogy and biochemical engineering, are major forces driving the steady increase of approved biotech products, especially biopharmaceuticals, in the market. Today mammalian cell products (“products from cells”), primarily monoclonals, cytokines, recombinant glycoproteins, and, increasingly, vaccines, dominate the biopharmaceutical industry. Moreover, a small number of products consisting of in vitro cultivated cells (“cells as product”) for regenerative medicine have also been introduced in the market. Their efficient production requires comprehensive knowledge of biological as well as biochemical mammalian cell culture fundamentals (e.g., cell characteristics and metabolism, cell line establishment, culture medium optimization) and related engineering principles (e.g., bioreactor design, process scale-up and optimization). In addition, new developments focusing on cell line development, animal-free c- ture media, disposables and the implications of changing processes (multi-purpo- facilities) have to be taken into account. While a number of excellent books treating the basic methods and applications of mammalian cell culture technology have been published, only little attention has been afforded to their engineering aspects. The aim of this book is to make a contribution to closing this gap; it particularly focuses on the interactions between biological and biochemical and engineering principles in processes derived from cell cultures. It is not intended to give a c- prehensive overview of the literature. This has been done extensively elsewhere.
Dynamic Single-Use Bioreactors Used in Modern Liter- and m3- Scale Biotechnological Processes: Engineering Characteristics and Scaling Up, by Christian Löffelholz, Stephan C. Kaiser, Matthias Kraume, Regine Eibl , Dieter Eibl. Orbitally Shaken Single-Use Bioreactors, by Wolf Klöckner, Sylvia Diederichs, Jochen Büchs. Therapeutic Human Cells: Manufacture for Cell Therapy/Regenerative Medicine by Christian van den Bos, Robert Keefe, Carmen Schirmaier, Michael McCaman. Fast Single-Use VLP Vaccine Productions Based on Insect Cells and the Baculovirus Expression Vector System: Influenza as Case Study by Regine Eibl, Nina Steiger, Sabine Wellnitz, Tiago Vicente, Corinne John, Dieter Eibl. Microbial High Cell Density Fermentations in a Stirred Single-Use Bioreactor by Thomas Dreher, Bart Walcarius, Ute Husemann, Franziska Klingenberg, Christian Zahnow, Thorsten Adams, Davy de Wilde, Peter Casteels, Gerhard Greller. Quorus Bioreactor: A New Perfusion-Based Technology for Microbial Cultivation by Sheena J. Fraser, Christian Endres. Cultivation of Marine Microorganisms in Single-Use Systems by Friederike Hillig, Maciej Pilarek, Stefan Junne, Peter Neubauer. Flexible Biomanufacturing Processes that Address the Needs of the Future by Bernhard Diel, Christian Manzke, Thorsten Peuker. An Approach to Quality and Security of Supply for Single-Use Bioreactors by Magali Barbaroux, Susanne Gerighausen, Heiko Hackel. A Risk Analysis for Production Processes with Disposable Bioreactors by Tobias Merseburger, Ina Pahl, Daniel Müller, Markus Tanner.
Animal cells are the preferred “cell factories” for the production of complex molecules and antibodies for use as prophylactics, therapeutics or diagnostics. Animal cells are required for the correct post-translational processing (including glycosylation) of biopharmaceutical protein products. They are used for the production of viral vectors for gene therapy. Major targets for this therapy include cancer, HIV, arthritis, cardiovascular and CNS diseases and cystic fibrosis. Animal cells are used as in vitro substrates in pharmacological and toxicological studies. This book is designed to serve as a comprehensive review of animal cell culture, covering the current status of both research and applications. For the student or R&D scientist or new researcher the protocols are central to the performance of cell culture work, yet a broad understanding is essential for translation of laboratory findings into the industrial production. Within the broad scope of the book, each topic is reviewed authoritatively by experts in the field to produce state-of-the-art collection of current research. A major reference volume on cell culture research and how it impacts on production of biopharmaceutical proteins worldwide, the book is essential reading for everyone working in cell culture and is a recommended volume for all biotechnology libraries.
Animal Cell Biotechnology: Methods and Protocols, Third Edition constitutes a comprehensive manual of state-of-the-art and new techniques for setting up mammalian cell lines for production of biopharmaceuticals, and for optimizing critical parameters for cell culture from lab to final production. The volume is divided into five parts that reflect the processes required for different stages of production. In Part I, basic techniques for establishment of production cell lines are addressed, especially high-throughput synchronization, insect cell lines, transient gene and protein expression, DNA Profiling and Characterisation. Part II addresses tools for process and medium optimization as well as microcarrier technology while Part III covers monitoring of cell growth, viability and apoptosis, metabolic flux estimation, quenching methods as well as NMR-based techniques. Part IV details cultivation techniques, and Part V describes special applications, including vaccine production, baculovirus protein expression, chromatographic techniques for downstream as well as membrane techniques for virus separation. Written in the successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Animal Cell Biotechnology: Methods and Protocols, Third Edition provides a compendium of techniques for scientists in industrial and research laboratories that use mammalian cells for biotechnology purposes.
Edited by two of the most distinguished pioneers in genetic manipulation and bioprocess technology, this bestselling reference presents a comprehensive overview of current cell culture technology used in the pharmaceutical industry. Contributions from several leading researchers showcase the importance of gene discovery and genomic technology devel
