Download or read book Potency Assays for Advanced Stem Cell Therapy Medicinal Products written by Jorge S. Burns and published by . This book was released on 2023 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental evaluations that critically influence stem cell regenerative medicine. Developing potency assays for cell-based medicinal products comes with numerous challenges due to the highly specialised nature of the application and purpose. This book provides the reader with the knowledge necessary to understand issues governing the successful development of potency assays, highlighting an international outlook of how the various challenges raised are being managed. Stakeholders concerned with potency assay development range from patient and clinician to contract research organisations, small and medium enterprise, regulatory authorities and even politicians. The value of potency assays is poised to increase given the inevitable watershed as early-stage clinical trials addressing safety progress to trials testing efficacy. Contributors from clinical, academic, industrial and regulatory sectors establish a broad point of view for guidance and timely debate. Potency assays require extensive collaboration across disciplines and sectors, as well as compromise and the authors aim to constructively address the many key aspects involved. Potency assays provide a quantitative measure of the biological activity of advanced therapy medicinal products (ATMPs) and thus are required for their market authorization. As the pace of ATMP development accelerates, the need to develop specific, accurate, and robust potency assays for each product is also accelerating. The volume Potency Assays for Stem Cell Advanced Therapy Medicinal Products presents a broad outlook on the development, quality attributes, and implementation of potency assays for ATMPs. The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potency assay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval. Subsequent chapters highlight efforts to develop potency assays for specific ATMPs, including skeletal stem cells, mesenchymal stromal cells, extracellular vesicles, CAR T-cells, and discuss emerging technologies/platforms for potency assay design. The volume concludes with a chapter reviewing potency assays used for the release of commercial ATMP products, which amalgamates information contained in previous chapters. Overall, the knowledge contributed from leading authorities in both academia and industry is an ideal resource for technicians, scientists, clinicians, process engineers, and regulators working with ATMPs. -Donald G. Phinney, PhD Professor, Department of Molecular Medicine, Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology .

Download or read book Potency Assays for Advanced Stem Cell Therapy Medicinal Products written by Jorge S. Burns and published by Springer Nature. This book was released on 2023-05-31 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume of the Springer book series Advances in Experimental Medicine and Biology covers potency assays, one of the most complex yet fundamental evaluations that critically influence stem cell regenerative medicine. Developing potency assays for cell-based medicinal products comes with numerous challenges due to the highly specialised nature of the application and purpose. This book provides the reader with the knowledge necessary to understand issues governing the successful development of potency assays, highlighting an international outlook of how the various challenges raised are being managed. Stakeholders concerned with potency assay development range from patient and clinician to contract research organisations, small and medium enterprise, regulatory authorities and even politicians. The value of potency assays is poised to increase given the inevitable watershed as early-stage clinical trials addressing safety progress to trials testing efficacy. Contributors from clinical, academic, industrial and regulatory sectors establish a broad point of view for guidance and timely debate. Potency assays require extensive collaboration across disciplines and sectors, as well as compromise and the authors aim to constructively address the many key aspects involved. Potency assays provide a quantitative measure of the biological activity of advanced therapy medicinal products (ATMPs) and thus are required for their market authorization. As the pace of ATMP development accelerates, the need to develop specific, accurate, and robust potency assays for each product is also accelerating. The volume Potency Assays for Stem Cell Advanced Therapy Medicinal Products presents a broad outlook on the development, quality attributes, and implementation of potency assays for ATMPs. The first few chapters introduce a nuanced historical perspective on the science of potency assay development, describe specific quality attributes of an idealized potency assay, indicate pitfalls associated with developing such assays for ATMPs, and review guidance recommended by regulatory authorities on assay suitability for product approval. Subsequent chapters highlight efforts to develop potency assays for specific ATMPs, including skeletal stem cells, mesenchymal stromal cells, extracellular vesicles, CAR T-cells, and discuss emerging technologies/platforms for potency assay design. The volume concludes with a chapter reviewing potency assays used for the release of commercial ATMP products, which amalgamates information contained in previous chapters. Overall, the knowledge contributed from leading authorities in both academia and industry is an ideal resource for technicians, scientists, clinicians, process engineers, and regulators working with ATMPs. —Donald G. Phinney, PhD Professor, Department of Molecular Medicine, Herbert Wertheim UF Scripps Institute for Biomedical Innovation & Technology

Download or read book Mesenchymal Stem Cell Therapy written by Lucas G. Chase and published by Springer Science & Business Media. This book was released on 2012-12-12 with total page 458 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Hepatocyte Transplantation written by S. Gupta and published by Springer Science & Business Media. This book was released on 2002-09-30 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years there has been an increasing need for transplantation, but the number of donor livers available has increased only slightly, despite intensive public relations activities. New concepts in the field of transplantation, for instance the transplantation of living donor organs or the splitting of organs, are urgently required, to safeguard the treatment of patients with severe liver disease. The development and clinical application of cell therapy for patients with liver disease could soon present a significant enhancement of the therapeutic options. The aim of such cell therapy is to repair or improve the biological function of the chronically and acutely damaged liver. Even though systematic trials are not available, individual case reports and small series already show promising clinical results. Present concepts of cell therapy for liver diseases based on the use of primary hepatocytes have recently been considerably extended through new data on the biology of stem cells. The adult haematopoetic stem cell as a pool for hepatocyte grafts - what would be the perspectives for the clinical application? This book is the proceedings of the Falk Symposium No. 126 on `Hepatocyte Transplantation' (Progress in Gastroenterology and Hepatology Part III) held in Hannover, Germany, October 2-3, 2001, and is a forum for basic research, but also for questions concerning clinical applications in the field of hepatocyte transplantation.

Download or read book Reparative Medicine written by Jean D. Sipe and published by . This book was released on 2002 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume covers topics that encompass the use of components of the body, such as genes, proteins, and cells, to either foster tissue regeneration and remodeling in vivo for the purpose of repairing, replacing, maintaining, or enhancing organ function,

Download or read book Human Embryonic Stem Cells written by Arlene Chiu and published by Springer Science & Business Media. This book was released on 2003-08 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: A discussion of all the key issues in the use of human pluripotent stem cells for treating degenerative diseases or for replacing tissues lost from trauma. On the practical side, the topics range from the problems of deriving human embryonic stem cells and driving their differentiation along specific lineages, regulating their development into mature cells, and bringing stem cell therapy to clinical trials. Regulatory issues are addressed in discussions of the ethical debate surrounding the derivation of human embryonic stem cells and the current policies governing their use in the United States and abroad, including the rules and conditions regulating federal funding and questions of intellectual property.

Download or read book Perinatal Stem Cells written by Anthony Atala and published by Academic Press. This book was released on 2018-06-14 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perinatal Stem Cells provides researchers and clinicians with a comprehensive description of the current clinical and pre-clinical applications of stem cells derived from perinatal sources, such as amniotic fluid, placenta and placental membranes, the umbilical cord and Wharton’s jelly. It's compiled by leading experts in the field, offering readers detailed insights into sources of perinatal stem cells and their potential for disease treatment. Therapeutic applications of perinatal stem cells include the treatment of in utero and pregnancy related diseases, cardiac disease, liver disease, pulmonary disease, inflammatory diseases, for hematopoietic regeneration, and for neural protection after stroke or traumatic brain injury. In addition, the rapid advance in clinical translation and commercialization of perinatal stem cell therapies is highlighted in a section on Clinical and Industry Perspective which provides insight into the new opportunities and challenges involved in this novel and exciting industry. Explores current clinical and pre-clinical application of stem cells derived from perinatal sources Offers detailed insight into sources of perinatal stem cells and their potential for disease treatment Discusses progress in the manufacturing, banking and clinical translation of perinatal stem cells Edited by a world-renowned team to present a complete story of the development and promise of perinatal stem cells

Download or read book Cell Therapy written by Adrian Gee and published by Springer Science & Business Media. This book was released on 2009-09-18 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Regulatory Aspects of Gene Therapy and Cell Therapy Products written by Maria Cristina Galli and published by Springer. This book was released on 2015-09-15 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.

Download or read book Neural Stem Cell Assays written by Navjot Kaur and published by John Wiley & Sons. This book was released on 2015-02-16 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: Neural stem cells offer a valuable model system for delineating the cellular and developmental processes in normal and diseased states of the central nervous system. In particular, neural stem cells have huge potential in regenerative medicine, owing to their expansion capability in culture and the ability to differentiate into multiple sub-neural lineages. Neural Stem Cell Assays provides a detailed and comprehensive review of the basic methods for neural stem cell cultures. Including an overview of progress in the field over the past decade, Neural Stem Cell Assays is a one-stop reference for consistent methods and reliable tools that span the entire assay work flow, from isolation or generation of neural stem cells to characterization, manipulation and final application of neural stem cells in disease paradigms such as Parkinson's disease, multiple sclerosis and amyotrophic lateral sclerosis. An excellent source of information for academic, pharmaceutical and biotechnology researchers who are new to the neural stem cell field, Neural Stem Cell Assays is an invaluable to experienced users who wish to integrate newly developed tools and technologies into their workflow. The book also covers important course material for students at the undergraduate and graduate level who are learning the basics of neural stem cell cultures, and differentiation to sub-neural lineages.

Download or read book Advances In Pharmaceutical Cell Therapy Principles Of Cell based Biopharmaceuticals written by Christine Guenther and published by World Scientific. This book was released on 2015-09-23 with total page 565 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Encyclopedia of Tissue Engineering and Regenerative Medicine written by and published by Academic Press. This book was released on 2019-06-03 with total page 1436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Encyclopedia of Tissue Engineering and Regenerative Medicine, Three Volume Set provides a comprehensive collection of personal overviews on the latest developments and likely future directions in the field. By providing concise expositions on a broad range of topics, this encyclopedia is an excellent resource. Tissue engineering and regenerative medicine are relatively new fields still in their early stages of development, yet they already show great promise. This encyclopedia brings together foundational content and hot topics in both disciplines into a comprehensive resource, allowing deeper interdisciplinary research and conclusions to be drawn from two increasingly connected areas of biomedicine. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the fields of tissue engineering and regenerative medicine Contains multimedia features, including hyperlinked references and further readings, cross-references and diagrams/images Represents the most comprehensive and exhaustive product on the market on the topic

Download or read book Cell and Gene Therapies written by Miguel-Angel Perales and published by Springer. This book was released on 2018-11-27 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Cardiovascular Regenerative Medicine written by Vahid Serpooshan and published by Springer. This book was released on 2019-06-29 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is a comprehensive and up-to-date resource on the use of regenerative medicine for the treatment of cardiovascular disease. It provides a much-needed review of the rapid development and evolution of bio-fabrication techniques to engineer cardiovascular tissues as well as their use in clinical settings. The book incorporates recent advances in the biology, biomaterial design, and manufacturing of bioengineered cardiovascular tissue with their clinical applications to bridge the basic sciences to current and future cardiovascular treatment. The book begins with an examination of state-of-the-art cellular, biomaterial, and macromolecular technologies for the repair and regeneration of diseased heart tissue. It discusses advances in nanotechnology and bioengineering of cardiac microtissues using acoustic assembly. Subsequent chapters explore the clinical applications and translational potential of current technologies such as cardiac patch-based treatments, cell-based regenerative therapies, and injectable hydrogels. The book examines how these methodologies are used to treat a variety of cardiovascular diseases including myocardial infarction, congenital heart disease, and ischemic heart injuries. Finally, the volume concludes with a summary of the most prominent challenges and perspectives on the field of cardiovascular tissue engineering and clinical cardiovascular regenerative medicine. Cardiovascular Regenerative Medicine is an essential resource for physicians, residents, fellows, and medical students in cardiology and cardiovascular regeneration as well as clinical and basic researchers in bioengineering, nanomaterial and technology, and cardiovascular biology.

Download or read book Medicines from Animal Cell Culture written by Glyn N. Stacey and published by John Wiley & Sons. This book was released on 2007-06-29 with total page 696 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicines from Animal Cell Culture focuses on the use of animal cell culture, which has been used to produce human and veterinary vaccines, interferon, monoclonal antibodies and genetically engineered products such as tPA and erythropoietin. It also addresses the recent dramatic expansion in cell-based therapies, including the use of live cells for tissue regeneration and the culture of stem cells. Medicines from Animal Cell Culture: Provides comprehensive descriptions of methods for cell culture and nutrition as well as the technologies for the preservation and characterisation of both the cells and the derived products Describes the preparation of stem cells and others for use in cell-based therapies – an area of burgeoning research Includes experimental examples to indicate expected results Covers regulatory issues from the UK, the EU and the USA and reviews how these are developing around the world Addresses the key issues of standardisation and validation with chapters on GLP and GMP for cell culture processes Delivering insight into the exciting world of biological medicines and directions for further investigation into specific topics, Medicines from Animal Cell Culture is an essential resource for researchers and technicians at all levels using cell culture within the pharmaceutical, biotechnology and biomedical industries. It is of value to laboratory managers in these industries and to all those interested in this topic alike.

Download or read book Stem Cells in Clinical Practice and Tissue Engineering written by Rakesh Sharma and published by BoD – Books on Demand. This book was released on 2018-05-02 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stem Cells in Clinical Practice and Tissue Engineering is a concise book on applied methods of stem cell differentiation and optimization using tissue engineering methods. These methods offer immediate use in clinical regenerative medicine. The present volume will serve the purpose of applied stem cell differentiation optimization methods in clinical research projects, as well as be useful to relatively experienced stem cell scientists and clinicians who might wish to develop their stem cell clinical centers or research labs further. Chapters are arranged in the order of basic concepts of stem cell differentiation, clinical applications of pluripotent stem cells in skin, cardiac, bone, dental, obesity centers, followed by tissue engineering, new materials used, and overall evaluation with their permitted legal status.

Download or read book Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy written by Mahmoud Aljurf and published by Springer Nature. This book was released on 2021-02-19 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book provides a concise yet comprehensive overview on how to build a quality management program for hematopoietic stem cell transplantation (HSCT) and cellular therapy. The text reviews all the essential steps and elements necessary for establishing a quality management program and achieving accreditation in HSCT and cellular therapy. Specific areas of focus include document development and implementation, audits and validation, performance measurement, writing a quality management plan, the accreditation process, data management, and maintaining a quality management program. Written by experts in the field, Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy: A Practical Guide is a valuable resource for physicians, healthcare professionals, and laboratory staff involved in the creation and maintenance of a state-of-the-art HSCT and cellular therapy program.