The next healthcare revolution will apply regenerative medicines using human cells and tissues. The aim of the regenerative medicine approach is to create biological therapies or substitutes in vitro for the replacement or restoration of tissue function in vivo lost through failure or disease. However, whilst science has revealed the potential, and early products have shown the power of such therapies, there is an immediate and long-term need for expertise with the necessary skills to face the engineering and life science challenges before the predicted benefits in human healthcare can be realized. Specifically, there is a need for the development of bioprocess technology for the successful transfer of laboratory-based practice of stem cell and tissue culture to the clinic as therapeutics through the application of engineering principles and practices. This Special Issue of Bioengineering on Stem Cell Bioprocessing and Manufacturing addresses the central role in defining the engineering sciences of cell-based therapies, by bringing together contributions from worldwide experts on stem cell biology and engineering, bioreactor design and bioprocess development, scale-up, and manufacturing of stem cell-based therapies.

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

This book is a unique guide to emerging stem cell technologies and the opportunities for their commercialisation. It provides in-depth analyses of the science, business, legal, and financing fundamentals of stem cell technologies, offering a holistic assessment of this emerging and dynamic segment of the field of regenerative medicine. • Reviews the very latest advances in the technology and business of stem cells used for therapy, research, and diagnostics • Identifies key challenges to the commercialisation of stem cell technology and avenues to overcome problems in the pipeline • Written by an expert team with extensive experience in the business, basic and applied science of stem cell research This comprehensive volume is essential reading for researchers in cell biology, biotechnology, regenerative medicine, and tissue engineering, including scientists and professionals, looking to enter commercial biotechnology fields.

This book describes a global assessment of stem cell engineering research, achieved through site visits by a panel of experts to leading institutes, followed by dedicated workshops. The assessment made clear that engineers and the engineering approach with its quantitative, system-based thinking can contribute much to the progress of stem cell research and development. The increased need for complex computational models and new, innovative technologies, such as high-throughput screening techniques, organ-on-a-chip models and in vitro tumor models require an increasing involvement of engineers and physical scientists. Additionally, this book will show that although the US is still in a leadership position in stem cell engineering, Asian countries such as Japan, China and Korea, as well as European countries like the UK, Germany, Sweden and the Netherlands are rapidly expanding their investments in the field. Strategic partnerships between countries could lead to major advances of the field and scalable expansion and differentiation of stem cells. This study was funded by the National Science Foundation (NSF), the National Institutes of Health (NIH) and the National Institute of Standards and Technology (NIST).

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

Written for industrial and academic researchers and development scientists in the life sciences industry, Bioprocessing Technology for Production of Biopharmaceuticals and Bioproducts is a guide to the tools, approaches, and useful developments in bioprocessing. This important guide: • Summarizes state-of-the-art bioprocessing methods and reviews applications in life science industries • Includes illustrative case studies that review six milestone bio-products • Discuses a wide selection of host strain types and disruptive bioprocess technologies

An international team of investigators presents thought-provoking reviews of bioreactors for stem cell expansion and differentiation and provides cutting-edge information on different bioreactor systems. The authors offer novel insights into bioreactor-based culture systems specific for tissue engineering, including sophisticated and cost-effective manufacturing strategies geared to overcome technological shortcomings that currently preclude advances towards product commercialization. This book in the fields of stem cell expansion, bioreactors, bioprocessing, and bio and tissue engineering, gives the reader a full understanding of the state-of-art and the future of these fields. Key selling features: Describes various bioreactors or stem cell culturing systems Reviews methods for stem cell expansion and differentiation for neural, cardiac, hemopoietic, mesenchymal, hepatic and other tissues cell types Distinguishes different types of bioreactors intended for different operational scales of tissue engineering and cellular therapies Includes contributions from an international team of leaders in stem cell research

Dr. Stephanie Willerth has a commercialization agreement with Aspect Biosystems with regards to bioprinting stem cell derived tissues. Dr. Yuguo Lei is a co-founder of CellGro Technologies, LLC, a company focusing on cell expansion technologies. Dr. Tiago Fernandes has no competing interests with regards to this Research Topic.

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

Immunotherapy with genetically engineered immune cell products is a transformative treatment modality with potential applications in various fields of medicine. A prime example is chimeric antigen receptor (CAR)-modified T cells in hematology and oncology, and the advent of CAR T cell therapies to treat infectious diseases, autoimmune disorders, and cardiovascular diseases. The medical need and demand from patients and caregivers require radical innovations to accelerate and improve pre-clinical development and clinical translation, provision of gene-transfer vectors, and immune cell product manufacturing as well as a critical reflection and discussion on ethical and socioeconomic aspects. The goal of this special issue of Frontiers in Immunology is to provide a comprehensive and multi-faceted view on the current state-of-the-art, imminent and future directions the field is taking in order to accelerate the pre-clinical development, clinical translation, and manufacturing of CAR T cells, increase access and sustainability of CAR T cell therapy for health care systems (in developed and in developing countries). This special issue will focus on the medical and scientific dimension incl. approved and emerging indications, new areas in medicine, advanced gene-transfer and gene-editing technologies, innovations in pre-clinical assessment (efficacy, toxicology, genomic safety), innovations in scalable automated manufacturing (bioprocessing), the implementation of high content data acquisition, machine learning and artificial intelligence, innovations in clinical trial design; and consider the ethical, socioeconomic and societal dimension of CAR T cells in particular and gene-engineered immune cell therapy in general.