With contributions from leading, international academics and industrial practitioners, Bioprocessing for Cell-Based Therapies explores the very latest techniques and guidelines in bioprocess production to meet safety, regulatory and ethical requirements, for the production of therapeutic cells, including stem cells. An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout In depth discussion of the application of cell therapy including methods used in the delivery of cells to the patient Includes contributions from experts in both academia and industry, combining a practical approach with cutting edge research The only handbook currently available to provide a state of the art guide to Bioprocessing covering the complete range of cell-based therapies, from experts in academia and industry
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
Stem Cell Manufacturing discusses the required technologies that enable the transfer of the current laboratory-based practice of stem cell tissue culture to the clinic environment as therapeutics, while concurrently achieving control, reproducibility, automation, validation, and safety of the process and the product. The advent of stem cell research unveiled the therapeutic potential of stem cells and their derivatives and increased the awareness of the public and scientific community for the topic. The successful manufacturing of stem cells and their derivatives is expected to have a positive impact in the society since it will contribute to widen the offer of therapeutic solutions to the patients. Fully defined cellular products can be used to restore the structure and function of damaged tissues and organs and to develop stem cell-based cellular therapies for the treatment of cancer and hematological disorders, autoimmune and other inflammatory diseases and genetic disorders. - Presents the first 'Flowchart' of stem cell manufacturing enabling easy understanding of the various processes in a sequential and coherent manner - Covers all bioprocess technologies required for the transfer of the bench findings to the clinic including the process components: cell signals, bioreactors, modeling, automation, safety, etc. - Presents comprehensive coverage of a true multidisciplinary topic by bringing together specialists in their particular area - Provides the basics of the processes and identifies the issues to be resolved for large scale cell culture by the bioengineer - Addresses the critical need in bioprocessing for the successful delivery of stem cell technology to the market place by involving professional engineers in sections of the book
Stem cell bioprocessing describes the main large-scale bioprocessing strategies for both stem cell culture and purification, envisaging the application of these cells for regenerative medicine and drug screening. Bioreactor configurations are described, including their applications for stem cell expansion, and stem cell separation techniques such as isolation and purification are discussed. Basic definitions are provided concerning the different types of stem cells, from adult stem cells to the more recent induced pluripotent stem cells. The main characteristics of these different stem cell types are described, alongside the molecular mechanisms underlying their self-renewal and differentiation. The book also focuses on methodologies currently used for in vitro stem cell culture under static conditions, including the challenge of xeno-free culture conditions, as well as culture parameters that influence stem cell culture. Approaches for both stem cell culture and separation in micro-scale conditions are presented, including the use of cellular microarrays for high-throughput screening of the effect of both soluble and extracellular matrix molecules. A further section is dedicated to application of stem cells for regenerative medicine. - Maintains a unique focus on both the basic stem cell biology concepts, and their translation to large-scale bioprocessing approaches - Envisages the use of stem cells in regenerative medicine and drug screening applications - Discusses the application of microscale techniques as a tool to perform basic stem cell biology studies
With contributions from leading, international academics and industrial practitioners, Bioprocessing for Cell-Based Therapies explores the very latest techniques and guidelines in bioprocess production to meet safety, regulatory and ethical requirements, for the production of therapeutic cells, including stem cells. An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout In depth discussion of the application of cell therapy including methods used in the delivery of cells to the patient Includes contributions from experts in both academia and industry, combining a practical approach with cutting edge research The only handbook currently available to provide a state of the art guide to Bioprocessing covering the complete range of cell-based therapies, from experts in academia and industry
Over the past decade, significant efforts have been made to develop stem cell-based therapies for difficult to treat diseases. Multipotent mesenchymal stromal cells, also referred to as mesenchymal stem cells (MSCs), appear to hold great promise in regards to a regenerative cell-based therapy for the treatment of these diseases. Currently, more than 200 clinical trials are underway worldwide exploring the use of MSCs for the treatment of a wide range of disorders including bone, cartilage and tendon damage, myocardial infarction, graft-versus-host disease, Crohn’s disease, diabetes, multiple sclerosis, critical limb ischemia and many others. MSCs were first identified by Friendenstein and colleagues as an adherent stromal cell population within the bone marrow with the ability to form clonogenic colonies in vitro. In regards to the basic biology associated with MSCs, there has been tremendous progress towards understanding this cell population’s phenotype and function from a range of tissue sources. Despite enormous progress and an overall increased understanding of MSCs at the molecular and cellular level, several critical questions remain to be answered in regards to the use of these cells in therapeutic applications. Clinically, both autologous and allogenic approaches for the transplantation of MSCs are being explored. Several of the processing steps needed for the clinical application of MSCs, including isolation from various tissues, scalable in vitro expansion, cell banking, dose preparation, quality control parameters, delivery methods and numerous others are being extensively studied. Despite a significant number of ongoing clinical trials, none of the current therapeutic approaches have, at this point, become a standard of care treatment. Although exceptionally promising, the clinical translation of MSC-based therapies is still a work in progress. The extensive number of ongoing clinical trials is expected to provide a clearer path forward for the realization and implementation of MSCs in regenerative medicine. Towards this end, reviews of current clinical trial results and discussions of relevant topics association with the clinical application of MSCs are compiled in this book from some of the leading researchers in this exciting and rapidly advancing field. Although not absolutely all-inclusive, we hope the chapters within this book can promote and enable a better understanding of the translation of MSCs from bench-to-bedside and inspire researchers to further explore this promising and quickly evolving field.
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.
In this book, experts in the field express their well-reasoned opinions on a range of complex, clinically relevant issues across the full spectrum of cell and gene therapies with the aim of providing trainee and practicing hematologists, including hematopoietic transplant physicians, with information that is relevant to clinical practice and ongoing research. Each chapter focuses on a particular topic, and the concise text is supported by numerous working tables, algorithms, and figures. Whenever appropriate, guidance is provided regarding the availability of potentially high-impact clinical trials. The rapid evolution of cell and gene therapies is giving rise to numerous controversies that need to be carefully addressed. In meeting this challenge, this book will appeal to all residents, fellows, and faculty members responsible for the care of hematopoietic cell transplant patients. It will also offer a robust, engaging tool to aid vital activities in the daily work of every hematology and oncology trainee.
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.
In stem cell research there are several key methods that, once mastered, can be extremely powerful. These methods enable you to rigorously test hypotheses, compare results to "gold standards," and may even spur improvements to existing protocols. This book describes numerous methods to derive, manipulate, target, and prepare stem cells for clinical use. The methods described here help you derive and test human embryonic stem cells, analyze bone marrow stem cell function in vitro and in vivo, image a stem cell transplant, cryopreserve stem cells and differentiate stem cells using microscale tec.
