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Stem Cell Manufacturing

Stem Cell Manufacturing
A Book

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

  • Publisher : Elsevier
  • Release : 2016-07-24
  • Pages : 340
  • ISBN : 0444632662
  • Language : En, Es, Fr & De
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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

Novel Perspectives of Stem Cell Manufacturing and Therapies
A Book

by Diana Kitala,Ana Colette Maurício

  • Publisher : BoD – Books on Demand
  • Release : 2021-04-14
  • Pages : 178
  • ISBN : 1839625031
  • Language : En, Es, Fr & De
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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 Cells and Good Manufacturing Practices

Stem Cells and Good Manufacturing Practices
Methods, Protocols, and Regulations

by Kursad Turksen

  • Publisher : Humana
  • Release : 2021-04-01
  • Pages : 288
  • ISBN : 9781071613269
  • Language : En, Es, Fr & De
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This detailed book explores the utilization and delivery of stem cells for therapeutic purposes in patients in the clinic and the tightly controlled Good Manufacturing Practices (GMP) that make these powerful techniques possible. Fully updated and expanded from the first edition, this collection features a new set of protocols to arm stem cell biologists with protocols that are currently being used in a number of well-established facilities around the world. Written for the highly successful Methods in Molecular Biology series, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and up to date, Stem Cells and Good Manufacturing Practices: Methods, Protocols, and Regulations, Second Edition serves as an ideal guide for researchers aiming to drive continued improvements to GMP and accelerate new stem cell treatments for patients in need.

Mesenchymal Stem Cell Manufacturing for Clinical Use

Mesenchymal Stem Cell Manufacturing for Clinical Use
A Book

by Franca Fagioli

  • Publisher : Unknown Publisher
  • Release : 2015
  • Pages : 129
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Mesenchymal stromal/stem cells (MSCs) are adult, self-renewable, multipotent cells that can be isolated in various tissues, most commonly bone marrow (BM) and adipose tissue. Because of their capacity for self-renewal and differentiation into tissues of mesodermal origin and due to their immunomodulatory ability, MSCs are used in many preclinical and clinical studies as possible new therapeutic agents for the treatment of a very broad range of conditions, including heart, hepatic, and neurodegenerative diseases.

Stem Cell Bioprocessing and Manufacturing

Stem Cell Bioprocessing and Manufacturing
A Book

by Joaquim M. S. Cabral,Cláudia Lobato da Silva,Maria Margarida Diogo

  • Publisher : MDPI
  • Release : 2021-01-20
  • Pages : 170
  • ISBN : 3039430386
  • Language : En, Es, Fr & De
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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 and Cell Therapy

Stem Cells and Cell Therapy
A Book

by Mohamed Al-Rubeai,Mariam Naciri

  • Publisher : Springer Science & Business Media
  • Release : 2013-10-01
  • Pages : 189
  • ISBN : 9400771967
  • Language : En, Es, Fr & De
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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.

Stem Cells in Regenerative Medicine

Stem Cells in Regenerative Medicine
Science, Regulation and Business Strategies

by Alain A. Vertes,Nasib Qureshi,Arnold I. Caplan,Lee E. Babiss

  • Publisher : John Wiley & Sons
  • Release : 2015-12-02
  • Pages : 776
  • ISBN : 111997139X
  • Language : En, Es, Fr & De
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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.

Perinatal Stem Cells

Perinatal Stem Cells
Biology, Manufacturing and Translational Medicine

by Zhong Chao Han,Tsuneo A. Takahashi,Zhibo Han,Zongjin Li

  • Publisher : Springer
  • Release : 2019-04-06
  • Pages : 173
  • ISBN : 9811327033
  • Language : En, Es, Fr & De
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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

Mesenchymal Stromal Cells
Translational Pathways to Clinical Adoption

by Hematti Peiman,Sowmya Viswanathan

  • Publisher : Academic Press
  • Release : 2016-08-11
  • Pages : 362
  • ISBN : 0128028408
  • Language : En, Es, Fr & De
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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

Perinatal Tissue-Derived Stem Cells

Perinatal Tissue-Derived Stem Cells
Alternative Sources of Fetal Stem Cells

by Babak Arjmand

  • Publisher : Springer
  • Release : 2016-12-01
  • Pages : 239
  • ISBN : 3319464108
  • Language : En, Es, Fr & De
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This book covers several aspects of perinatal tissue-derived stem cells, from theoretical concepts to clinical applications. Topics include functions and different sources, immunomodulatory properties, translational point of view, GMP facility design and manufacturing for clinical translation, therapeutic potentials, and finally ethical considerations. The text provides a brief review of each type of perinatal stem cells and then focuses on their multi- or pluripotent properties, regenerative capacity, and future therapeutic potential in regenerative medicine. Additionally, the book discusses GMP compliance in stem cell facilities and the manufacture of stem cells for clinical translation. The chapters are authored by world-renowned experts in the perinatal stem cell field. Perinatal Tissue-Derived Stem Cells: Alternative Sources of Fetal Stem Cells, part of Springer’s Stem Cell Biology and Regenerative Medicine series, is essential reading for basic and clinical scientists, clinicians, and pharmaceutical experts working or conducting research in the fields of stem cell biology, molecular aspects of stem cell research, tissue engineering, regenerative medicine, and cellular therapy.

Perinatal Stem Cells

Perinatal Stem Cells
A Book

by Anthony Atala,Sean V. Murphy

  • Publisher : Springer
  • Release : 2014-08-28
  • Pages : 373
  • ISBN : 149391118X
  • Language : En, Es, Fr & De
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This comprehensive volume is one of the first books to offer the reader detailed insight into sources of perinatal stem cells, their biology, and their potential for disease treatment. It examines the research and therapeutic applications of perinatal stem cells including the treatment of renal disease, hematopoietic regeneration, cardiac disease, inflammatory disease, bone regeneration, pulmonary disease, and the treatment of spinal cord injury. Further, the book discusses current progress in the manufacturing, banking and clinical translation of perinatal stem cells. Through this book, readers will gain a thorough understanding of the current pre-clinical and clinical applications of perinatal stem cells as well as the efforts to support the transition of perinatal stem cell therapies from laboratories to clinics. Perinatal Stem Cells contains thirty-two chapters written by internationally recognized leaders in stem cell research. It is organized into four sections covering amniotic fluid stem cells, placental and placental membrane stem cells, umbilical cord stem cells, and clinical translation. This cohesive structure provides an effective framework for detailed insight into this new frontier. Edited by Dr. Anthony Atala, one of the foremost experts in the field, and his co-editor Dr. Sean V. Murphy, this volume is a definitive work for stem cell research and its future implications. It is a key resource for all stem cell researchers, clinicians, and government and industry staff working in this dynamic and exciting field.

Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies

Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies
Proceedings of a Workshop

by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Forum on Regenerative Medicine

  • Publisher : National Academies Press
  • Release : 2018-01-29
  • Pages : 124
  • ISBN : 0309466474
  • Language : En, Es, Fr & De
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On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment. This publication summarizes the presentations and discussions from the workshop.

Cell Therapy

Cell Therapy
cGMP Facilities and Manufacturing

by Adrian Gee

  • Publisher : Springer
  • Release : 2014-12-03
  • Pages : 256
  • ISBN : 9781461497936
  • Language : En, Es, Fr & De
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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.

Stem Cells and Cell Therapy

Stem Cells and Cell Therapy
A Book

by Mohamed Al-Rubeai,Mariam Naciri

  • Publisher : Springer
  • Release : 2013-10-15
  • Pages : 189
  • ISBN : 9789400771956
  • Language : En, Es, Fr & De
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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.

Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals

Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals
A Book

by Huss Ralf,Guenther Christine,Hauser Andrea Josefine

  • Publisher : World Scientific
  • Release : 2015-09-23
  • Pages : 564
  • ISBN : 981461680X
  • Language : En, Es, Fr & De
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This textbook is a comprehensive overview of the development of cell-based biopharmaceuticals. Beginning with the underlying biology of stem cell and cell-based products, it traces the long and complex journey from preclinical concept to initiation of a pivotal clinical trial and the potential business model behind it.The book also takes into consideration the different regulatory landscapes and their continuous evolution in Europe, North America and other parts of the world. The authors describe a path to manufacture a clinical grade therapeutic that passes all necessary quality measures as a robust and marketable product including an outlook on next generation products and innovative strategies.This reference book is a must-have guide for any professional already active in biopharmaceuticals and anyone interested in getting involved in a scientific, medical or business capacity.

Stem Cell-based Tissue Repair

Stem Cell-based Tissue Repair
A Book

by Raphael Gorodetsky,Richard Schäfer

  • Publisher : Royal Society of Chemistry
  • Release : 2011
  • Pages : 391
  • ISBN : 1849730016
  • Language : En, Es, Fr & De
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This unique book by leading experts reviews the key therapeutic issues related to stem cell technology.

Bioreactors for Stem Cell Expansion and Differentiation

Bioreactors for Stem Cell Expansion and Differentiation
A Book

by Joaquim M.S. Cabral,Claudia Lobato da Silva

  • Publisher : CRC Press
  • Release : 2018-09-03
  • Pages : 334
  • ISBN : 0429841825
  • Language : En, Es, Fr & De
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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

Bone and Cartilage Regeneration

Bone and Cartilage Regeneration
A Book

by Phuc Van Pham

  • Publisher : Springer
  • Release : 2017-01-24
  • Pages : 315
  • ISBN : 3319401440
  • Language : En, Es, Fr & De
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This invaluable resource discusses clinical applications with effects and side-effects of applications of stem cells in bone and cartilage regeneration. Each chapter is contributed by a pre-eminent scientist in the field and covers such topics as skeletal regeneration by mesenchymal stem cells, clinical improvement of mesenchymal stem cell injection in injured cartilage and osteoarthritis, Good manufacturing practice (GMP), minimal critera of stem cells for clinical applications, future directions of the discussed therapies and much more. Bone & Cartilage Regeneration and the other books in the Stem Cells in Clinical Applications series will be invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering.

Plurixcel: Emerging Technologies of Regenerative Medicine

Plurixcel: Emerging Technologies of Regenerative Medicine
A Book

by Xuejun H. Parsons

  • Publisher : Independently Published
  • Release : 2017-07-24
  • Pages : 500
  • ISBN : 9781521929131
  • Language : En, Es, Fr & De
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The limit capacity of heart muscle and brain cells for self-repair constitutes a significant challenge to traditional medicine for tissue and function restoration in seeking cures for a wide range of heart diseases and neurological disorders. Given their limited capacity for self-repair, cell-based therapy represents a promising therapeutic approach closest to provide a cure to restore normal tissue and function. However, the existing markets lack a scalable clinically-suitable human neuronal or heart cell source with adequate regenerative potential, which has been the major setback in developing safe and effective cell-based therapies. To date, the need to restore vital tissue and function for a wide range of neurological and heart diseases remains a daunting challenge to the conventional mode of drugs and treatments. The pluripotent human embryonic stem cells (hESC), the nature source of human pluripotent stem cells (hPSC), have unlimited expansion and differentiation capabilities, offering a practically inexhaustible source of replacement cells for tissue and function restoration. Therefore, they have been regarded as an ideal source to provide an unlimited supply of clinically-relevant functional human cells to heal the damaged or lost tissues that have naturally limited capacity for self-repair, such as the human brain and heart. As neurological and heart diseases incur exorbitant costs on the healthcare system worldwide, there is a strong focus on translating hPSC research to provide newer, more efficient solutions for these unmet therapeutic needs. However, a persistent challenge for clinical translation is to enable a well-controlled and efficient induction of non-functional hPSC exclusively and uniformly to a specific clinically relevant functional lineage. PluriXcel is a pioneer in stem cell therapeutics and remarkable advancement in stem cell research related to the differentiation of non-functional hPSC into specific functional lineages by small molecule induction. The PluriXcel technology platforms offer currently the only available human cell products with the pharmacological capacity to regenerate neurons and contractile heart muscles that allow restitution of function in the clinic. PluriXcel technological breakthroughs allow the achievement of a highly efficient direct conversion of clinical-grade hPSC into a large supply of high-purity human neuronal cells or heart muscle cells with adequate capacity to regenerate neurons or contractile heart muscles for cell regeneration or replacement therapies, as well as for tissue or organ biofabrication. The PluriXcel platforms not only constitute clinically representative progresses in both human neuronal and cardiac therapeutic products for treating a wide range of incurable or hitherto untreatable neurological and heart diseases, but also offer manufacturing innovations for production scale-up and creation of replacement human tissue and organ products. Medical innovations of PluriXcel technology provide scalable platforms to ensure a high degree of efficacy and safety of hPSC-derived cellular products, thus robust clinical benefits leading to therapies, for treating major human diseases challenging traditional medicine. Manufacturing innovations of PluriXcel technology provide scale-up cGMP manufacturing capability for production of large quantities of high quality clinical-grade hPSC-based cell therapy products to support clinical trials and tissue or organ engineering/biofabrication, improving the availability, reproducibility, accessibility, and standardization of manufacturing materials, technologies, and processes to create human repairing or replacing cell, tissue, and organ products. Medical and manufacturing innovations of PluriXcel technology provide life scientists and clinicians with novel, efficient, and powerful resources and tools to address major health concerns, which will shape the future of medicine and bring new therapeutics into the market.

Guide to Cell Therapy GxP

Guide to Cell Therapy GxP
Quality Standards in the Development of Cell-Based Medicines in Non-pharmaceutical Environments

by Joaquim Vives,Gloria Carmona

  • Publisher : Academic Press
  • Release : 2015-07-24
  • Pages : 266
  • ISBN : 0128031166
  • Language : En, Es, Fr & De
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Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data Includes practical examples of successful implementation of quality standards