Stem Cell Manufacturing

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Stem Cell Manufacturing

Author : Joaquim M. S. Cabral,Claudia Lobato da Silva,Lucas G. Chase,Maria Margarida Diogo
Publisher : Elsevier
Page : 340 pages
File Size : 54,8 Mb
Release : 2016-07-24
Category : Medical
ISBN : 9780444632661

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Stem Cell Manufacturing by Joaquim M. S. Cabral,Claudia Lobato da Silva,Lucas G. Chase,Maria Margarida Diogo Pdf

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

Novel Perspectives of Stem Cell Manufacturing and Therapies

Author : Diana Kitala,Ana Colette Maurício
Publisher : BoD – Books on Demand
Page : 180 pages
File Size : 55,9 Mb
Release : 2021-04-14
Category : Technology & Engineering
ISBN : 9781839625039

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Novel Perspectives of Stem Cell Manufacturing and Therapies by Diana Kitala,Ana Colette Maurício Pdf

In the 1950s, Nobel Prize winner Dr. E. Donnall Thomas was the first to successfully transplant hematopoietic stem cells. Since then, studies on stem cells have evolved and expanded worldwide. There are more than 650,000 scientific publications on stem cells and more than 8000 stem cell clinical trials. This book summarizes types of stem cells, key studies, ongoing trials, and future perspectives. It also includes ethical, formal, and legal aspects to give the reader a comprehensive view of the field.

Stem Cell Bioprocessing and Manufacturing

Author : Joaquim M. S. Cabral,Cláudia Lobato da Silva,Maria Margarida Diogo
Publisher : MDPI
Page : 170 pages
File Size : 43,5 Mb
Release : 2021-01-20
Category : Science
ISBN : 9783039430383

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Stem Cell Bioprocessing and Manufacturing by Joaquim M. S. Cabral,Cláudia Lobato da Silva,Maria Margarida Diogo Pdf

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 Cells in Regenerative Medicine

Author : Alain A. Vertes,Nasib Qureshi,Arnold I. Caplan,Lee E. Babiss
Publisher : John Wiley & Sons
Page : 788 pages
File Size : 42,5 Mb
Release : 2015-12-02
Category : Science
ISBN : 9781119971399

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Stem Cells in Regenerative Medicine by Alain A. Vertes,Nasib Qureshi,Arnold I. Caplan,Lee E. Babiss Pdf

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.

Stem Cells and Good Manufacturing Practices

Author : Kursad Turksen
Publisher : Unknown
Page : 220 pages
File Size : 52,9 Mb
Release : 2015
Category : Cytology
ISBN : 1493924354

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Stem Cells and Good Manufacturing Practices by Kursad Turksen Pdf

This volume collects a series of protocols describing the kinds of infrastructures, training, and standard operating procedures currently available to actualize the potential of stem cells for regenerative therapies. Stem Cells and Good Manufacturing Practices: Methods, Protocols, and Regulations pulls together key GMP techniques from laboratories around the world. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Inclusive and authoritative, Stem Cells and Good Manufacturing Practices: Methods, Protocols, and Regulations will be an invaluable resource to both basic and clinical practitioners in stem cell biology.

Stem Cells and Cell Therapy

Author : Mohamed Al-Rubeai,Mariam Naciri
Publisher : Springer Science & Business Media
Page : 189 pages
File Size : 50,8 Mb
Release : 2013-10-01
Category : Medical
ISBN : 9789400771963

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Stem Cells and Cell Therapy by Mohamed Al-Rubeai,Mariam Naciri Pdf

With the discovery of stem cells capable of multiplying indefinitely in culture and differentiating into many other cell types in appropriate conditions, new hopes were born in repair and replacement of damaged cells and tissues. The features of stem cells may provide treatment for some incurable diseases with some therapies are already in clinics, particularly those from adult stem cells. Some treatments will require large number of cells and may also require multiple doses, generating a growing demand for generating and processing large numbers of cells to meet the need of clinical applications. With this in mind, our aim is to provide a book on the subject of stem cells and cell therapy for researchers and students of cell biotechnology, bioengineering and bioproduction. This book is exceptional as it teaches researchers stem cells and cell therapy in that it covers the concepts and backgrounds necessary so that readers get a good understanding of the production of stem cells. The book covers three topics: The basics of stem cells and cell therapy, the use of stem cells for the treatment of human diseases, and stem cell processing. It includes chapters on neural and vascular stem vascular stem cell therapy, expansion engineering of embryonic stem cells, stem cell based production of blood cells and separation technologies for stem cells and cell therapy products. It is an informed and informative presentation of what modern research, science and engineering have learned about stem cells and their production and therapies. Addressing both the medical and production issues, this book is an invaluable contribution to having an academic and industrial understanding with respect to R&D and manufacturing of clinical grade stem cells.

Cell Therapy

Author : Adrian Gee
Publisher : Springer Science & Business Media
Page : 256 pages
File Size : 40,6 Mb
Release : 2009-09-18
Category : Science
ISBN : 9780387895840

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Cell Therapy by Adrian Gee Pdf

Cell Therapy: cGMP Facilities and Manufacturing is the source for a complete discussion of facility design and operation with practical approaches to a variety of day-to-day activities, such as staff training and competency, cleaning procedures, and environmental monitoring. This in-depth book also includes detailed reviews of quality, the framework of regulations, and professional standards. It meets a previously unmet need for a thorough facility-focused resource, Cell Therapy: cGMP Facilities and Manufacturing will be an important addition to the cell therapy professional’s library. Additional topics in Cell Therapy: cGMP Facilities and Manufacturing...Standard operating procedures - Supply management - Facility equipment - Product manufacturing, review, release and administration - Facility master file.

Perinatal Stem Cells

Author : Zhong Chao Han,Tsuneo A. Takahashi,Zhibo Han,Zongjin Li
Publisher : Springer
Page : 0 pages
File Size : 54,8 Mb
Release : 2019-03-25
Category : Health & Fitness
ISBN : 9811327025

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Perinatal Stem Cells by Zhong Chao Han,Tsuneo A. Takahashi,Zhibo Han,Zongjin Li Pdf

This book provides a comprehensive introduction to various types of perinatal stem cells. Given their unique regenerative abilities, stem cells offer a promising avenue in the treatment of degenerative diseases or injury. Currently, the limitations of postnatal cell sources and expanding efficiency may limit autologous stem cell therapies. Although embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) can be cultured indefinitely ex vivo, and can differentiate into three germ layers, ethical issues, the teratoma formation of ESCs and oncogenic risk of iPSCs are major obstacles to their clinical application. More recently, perinatal stem cells have been isolated from the umbilical cord, Wharton’s Jelly, placenta, amniotic membrane and amniotic fluid, which are normally discarded as medical waste. This book, after describing perinatal stem cells in detail, introduces readers to the various types of perinatal stem cells, addressing their characterization, banking, quality control and stability. Importantly, it also reviews the clinical applications of perinatal stem cells to therapy of diseases. Accordingly, it offers a valuable resource for clinicians, researchers and graduate students alike.

Stem Cell and Tissue Engineering

Author : Song Li,Nicolas L'Heureux,Jennifer H. Elisseeff
Publisher : World Scientific
Page : 473 pages
File Size : 51,8 Mb
Release : 2011
Category : Science
ISBN : 9789814317054

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Stem Cell and Tissue Engineering by Song Li,Nicolas L'Heureux,Jennifer H. Elisseeff Pdf

Tissue engineering integrates knowledge and tools from biological sciences and engineering for tissue regeneration. A challenge for tissue engineering is to identify appropriate cell sources. The recent advancement of stem cell biology provides enormous opportunities to engineer stem cells for tissue engineering. The impact of stem cell technology on tissue engineering will be revolutionary. This book covers state-of-the-art knowledge on the potential of stem cells for the regeneration of a wide range of tissues and organs and the technologies for studying and engineering stem cells. It serves as a valuable reference book for researchers and students.

Stem Cell Production

Author : Firdos Alam Khan
Publisher : Unknown
Page : 0 pages
File Size : 54,5 Mb
Release : 2022
Category : Electronic
ISBN : 9811675902

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Stem Cell Production by Firdos Alam Khan Pdf

This book examines the technologies and processes for the development and commercial production of stem cells according to cGMP guidelines. The initial chapter of the book discusses the therapeutic potentials of stem cells for the treatment of various diseases, including degenerative disorders and genetic diseases. The book then reviews the recent developments in the cultivation of stem cells in bioreactors, including critical cultural parameters, possible bioreactor configuration and integrations of novel technologies in bioprocess developmental stages. The book also introduces microscopic, molecular, and cellular techniques for characterization of stem cells for regulatory approvals. Further, it describes optimal cell transporting conditions to maintain cell viability and properties. Further, it summarizes characterization strategies of clinical grade stem cells for stem cell therapy. This book is an invaluable contribution to having an academic and industrial understanding with respect to R&D and manufacturing of clinical grade stem cells.

Stem Cell-based Tissue Repair

Author : Raphael Gorodetsky,Richard Schäfer
Publisher : Royal Society of Chemistry
Page : 405 pages
File Size : 45,7 Mb
Release : 2011
Category : Medical
ISBN : 9781849730013

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Stem Cell-based Tissue Repair by Raphael Gorodetsky,Richard Schäfer Pdf

This unique book by leading experts reviews the key therapeutic issues related to stem cell technology.

Cell Therapy

Author : Adrian P. Gee
Publisher : Springer Nature
Page : 681 pages
File Size : 53,8 Mb
Release : 2021-11-10
Category : Science
ISBN : 9783030755379

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Cell Therapy by Adrian P. Gee Pdf

This new edition presents a fully-updated and expanded look at current Good Manufacturing Practice (cGMP) for cell therapy products. It provides a complete discussion of facility design and operation including details specific to cord blood banking, cell processing, vector production and qualification of a new facility. Several chapters cover facility infrastructure including cleaning and maintenance, vendor qualification, writing a Standard Operating Procedure, staff training, and process validation. The detailed and invaluable product information covers topics like labelling, release and administration, transportation and shipment, et al. Further chapters cover relevant topics like writing and maintaining investigational new drug applications, support opportunities in North America and the European Union, commercial cell processing and quality testing services, and financial considerations for academic GMP facilities. A chapter on future directions rounds out Cell Therapy: cGMP Facilities and Manufacturing making it essential reading for any cell therapy professional involved in the development, use, or management of this type of facility.

Bioreactors for Stem Cell Expansion and Differentiation

Author : Joaquim M.S. Cabral,Claudia Lobato da Silva
Publisher : CRC Press
Page : 279 pages
File Size : 49,5 Mb
Release : 2018-09-03
Category : Medical
ISBN : 9780429841811

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Bioreactors for Stem Cell Expansion and Differentiation by Joaquim M.S. Cabral,Claudia Lobato da Silva Pdf

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

Perinatal Stem Cells

Author : Zhong Chao Han,Tsuneo A. Takahashi,Zhibo Han,Zongjin Li
Publisher : Springer
Page : 173 pages
File Size : 40,6 Mb
Release : 2019-03-06
Category : Health & Fitness
ISBN : 9789811327032

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Perinatal Stem Cells by Zhong Chao Han,Tsuneo A. Takahashi,Zhibo Han,Zongjin Li Pdf

This book provides a comprehensive introduction to various types of perinatal stem cells. Given their unique regenerative abilities, stem cells offer a promising avenue in the treatment of degenerative diseases or injury. Currently, the limitations of postnatal cell sources and expanding efficiency may limit autologous stem cell therapies. Although embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) can be cultured indefinitely ex vivo, and can differentiate into three germ layers, ethical issues, the teratoma formation of ESCs and oncogenic risk of iPSCs are major obstacles to their clinical application. More recently, perinatal stem cells have been isolated from the umbilical cord, Wharton’s Jelly, placenta, amniotic membrane and amniotic fluid, which are normally discarded as medical waste. This book, after describing perinatal stem cells in detail, introduces readers to the various types of perinatal stem cells, addressing their characterization, banking, quality control and stability. Importantly, it also reviews the clinical applications of perinatal stem cells to therapy of diseases. Accordingly, it offers a valuable resource for clinicians, researchers and graduate students alike.

Mesenchymal Stromal Cells

Author : Hematti Peiman,Sowmya Viswanathan
Publisher : Academic Press
Page : 362 pages
File Size : 45,6 Mb
Release : 2016-08-11
Category : Medical
ISBN : 9780128028407

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Mesenchymal Stromal Cells by Hematti Peiman,Sowmya Viswanathan Pdf

Mesenchymal Stromal Cells: Translational Pathways to Clinical Adoption provides the latest information on the necessary steps for successful production of stem cells for a clinical trial. Written by professionals with hands-on experience in bringing MSC therapies to the clinic, and building on the biology and mechanisms of action, this unique book covers the development and production of clinical-grade products that are suitable for use in humans. From design of a cell production facility, to obtaining regulatory approval and reimbursement issues, it is a useful guide for researchers and administrators across biomedical research. Provides methodologies for clinical MSC production, from designing a facility, to post-market approval Includes real-life examples of MSC production in academic centers and MSC production for biopharmaceutical clinical trials Offers a unique perspective on the clinical aspects of MSC studies Presents the principles of clinical trials that can be applied to the production of various cell therapies