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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 throu...
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 ce...
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. Micro...
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 resear...
Computational fluid dynamics (CFD) is a powerful tool that enables engineers and scientists to simulate fluid flows in a variety of applications, including thermal engineering, biomedical engineering, and environmental modeling. This book provides a comprehensive introduction to CFD, encompassing fundamental theory, mathematical and numerical techniques, and practical applications. The book begins by systematically introducing the basic concepts and terminology of CFD, such as the continuity equation, Navier-Stokes equations, energy equation, source/sink terms, and types of grids. The mathematical and numerical methods utilized to solve the CFD governing equations, including the finite diffe...
The submersed cultivation of organisms in sterile containments or fermenters has become the standard manufacturing procedure, and will remain the gold standard for some time to come. This book thus addresses submersed cell culture and fermentation and its importance for the manufacturing industry. It goes beyond expression systems and integrally investigates all those factors relevant for manufacturing using suspension cultures. In so doing, the contributions cover all industrial cultivation methods in a comprehensive and comparative manner, with most of the authors coming from the industry itself. Depending on the maturity of the technology, the chapters address in turn the expression system, basic process design, key factors affecting process economics, plant and bioreactor design, and regulatory aspects.
This is the second of two volumes that together provide an overview of the latest advances in the generation and application of digital twins in bioprocess design and optimization. Both processes have undergone significant changes over the past few decades, moving from data-driven approaches into the 21st-century digitalization of the bioprocess industry. Moreover, the high demand for biotechnological products calls for efficient methods during research and development, as well as during tech transfer and routine manufacturing. In this regard, one promising tool is the use of digital twins, which offer a virtual representation of the bioprocess. They reflect the mechanistics of the biologica...
The bioactive compounds of plants have world-wide applications in pharmaceutical, nutraceutical and food industry with a huge market. In this book, a group of active researchers have addressed on the most recent advances in plant cell and organ cultures for the production of biomass and bioactive compounds using bioreactors. Tremendous efforts have been made to commercialize the production of plant metabolites by employing plant cell and organ cultures in bioreactors. This book emphasizes on the fundamental topics like designing of bioreactors for plant cell and organ cultures, various types of bioreactors including stirred tank, airlift, photo-bioreactor, disposable bioreactor used for plan...
Contains case studies illustrating the cell culture production of pigments, flavors, and antineoplastic compounds Plant Biotechnology and Transgenic Plants covers topics that range from food to fragrances to fuel. It includes discussions of technologies and research on the engineering, synthesis, utilization, and control of primary and secondary plant metabolites such as carbohydrates, amino acids, lipids, polymers, proteins, and phytochemicals for industrial, pharmaceutical, and food and feed applications. The editors put the emphasis on recent methods in farming, plant propagation, and breeding and modern procedures to formulate more effective biopharmaceuticals.
The second edition of this book constitutes a comprehensive manual of new techniques for setting up mammalian cell lines for production of biopharmaceuticals, and for optimizing critical parameters for cell culture considering the whole cascade from lab to final production. The chapters are written by world-renowned experts and the volume’s five parts reflect the processes required for different stages of production. This book is a compendium of techniques for scientists in both industrial and research laboratories that use mammalian cells for biotechnology purposes.