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Navigating The Manufacturing Process And Ensuring The Quality Of Regenerative Medicine Therapies
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Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309466474 Total Pages :125 pages Book Rating :4.3/5 (94 download)
Book Synopsis Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies by : National Academies of Sciences, Engineering, and Medicine
Download or read book Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-01-29 with total page 125 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher : ISBN 13 :9780309151825 Total Pages :170 pages Book Rating :4.1/5 (518 download)
Book Synopsis Applying Systems Thinking to Regenerative Medicine by : National Academies of Sciences, Engineering, and Medicine
Download or read book Applying Systems Thinking to Regenerative Medicine written by National Academies of Sciences, Engineering, and Medicine and published by . This book was released on 2021-12-26 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regenerative medicine products, which are intended to repair or replace damaged cells or tissues in the body, include a range of therapeutic approaches such as cell- and gene-based therapies, engineered tissues, and non-biologic constructs. The current approach to characterizing the quality of a regenerative medicine product and the manufacturing process often involves measuring as many endpoints as possible, but this approach has proved to be inadequate and unsustainable. The Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine convened experts across disciplines for a 2-day virtual public workshop to explore systems thinking approaches and how they may be applied to support the identification of relevant quality attributes that can help in the optimization of manufacturing and streamline regulatory processes for regenerative medicine. A broad array of stakeholders, including data scientists, physical scientists, industry researchers, regulatory officials, clinicians, and patient representatives, discussed new advances in data acquisition, data analysis and theoretical frameworks, and how systems approaches can be applied to the development of regenerative medicine products that can address the unmet needs of patients. This publication summarizes the presentation and discussion of the workshop.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309489121 Total Pages :133 pages Book Rating :4.3/5 (94 download)
Book Synopsis Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products by : National Academies of Sciences, Engineering, and Medicine
Download or read book Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-06-19 with total page 133 pages. Available in PDF, EPUB and Kindle. Book excerpt: The emerging multidisciplinary field of regenerative engineering is devoted to the repair, regeneration, and replacement of damaged tissues or organs in the body. To accomplish this it uses a combination of principles and technologies from disciplines such as advanced materials science, developmental and stem cell biology, immunology, physics, and clinical translation. The term "regenerative engineering" reflects a new understanding of the use of tissue engineering for regeneration and also the growing number of research and product development efforts that incorporate elements from a variety of fields. Because regenerative engineered therapies rely on live cells and scaffolds, there are inherent challenges in quality control arising from variability in source and final products. Furthermore, each patient recipient, tissue donor, and product application is unique, meaning that the field faces complexities in the development of safe and effective new products and therapies which are not faced by developers of more conventional therapies. Understanding the many sources of variability can help reduce this variability and ensure consistent results. The Forum on Regenerative Medicine hosted a public workshop on October 18, 2018, in Washington, DC, to explore the various factors that must be taken into account in order to develop successful regenerative engineering products. Invited speakers and participants discussed factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product to improve patient outcomes. This publication summarizes the presentation and discussion of the workshop.
Download or read book Cell Therapy written by Adrian P. Gee and published by Springer Nature. This book was released on 2021-11-10 with total page 681 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Mesenchymal Stromal Cells: Preclinical and Clinical Challenges by : Joan Oliva
Download or read book Mesenchymal Stromal Cells: Preclinical and Clinical Challenges written by Joan Oliva and published by Frontiers Media SA. This book was released on 2022-08-12 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Potency Assays for Advanced Stem Cell Therapy Medicinal Products by : Jorge S. Burns
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
Book Synopsis Regenerative Medicine by : Gustav Steinhoff
Download or read book Regenerative Medicine written by Gustav Steinhoff and published by Springer Science & Business Media. This book was released on 2013-03-20 with total page 1211 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of regenerative medicine has developed rapidly over the past 20 years with the advent of molecular and cellular techniques. This textbook, Regenerative Medicine: From Protocol to Patient, aims to explain the scientific knowledge and emerging technology as well as the clinical application in different organ systems and diseases. International leading experts from four continents describe the latest scientific and clinical knowledge of the field of regenerative medicine. The process of translating science of laboratory protocols into therapies is explained in sections on regulatory, ethical and industrial issues. This textbook is organized into five parts: (I) Biology of Tissue Regeneration, (II) Stem Cell Science and Technology, (III) Tissue Engineering, Biomaterials and Nanotechnology, (IV) Regenerative Therapies and (V) Regulation and Ethics. The textbook aims to give the student, the researcher, the health care professional, the physician and the patient a complete survey on the current scientific basis, therapeutical protocols, clinical translation and practiced therapies in regenerative medicine.
Book Synopsis Regenerative Medicine by : Gustav Steinhoff
Download or read book Regenerative Medicine written by Gustav Steinhoff and published by Springer Science & Business Media. This book was released on 2011-02-04 with total page 1031 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regenerative Medicine is a fastly emerging interdisciplinary field of research and clinical therapies on the repair, replacement or regeneration of cells, tissues or organs in congenital or acquired disease. This new field of research and clinical development focussing on stem cell science and regenerative biology is just starting to be the most fascinating and controversial medical development at the dawn of the 21st century. Viewing the great expectations to restructure and regenerate tissue, organs or organisms the current attempts of scientist and physicians are still in an early phase of development. This new textbook on “Regenerative Medicine – from protocol to patient” is aiming to explain the scientific knowledge and emerging technology as well as the clinical application in different organ systems and diseases. The international leading experts from four continents describe the latest scientific and clinical knowledge of the field of “Regenerative Medicine”. The process of translating science of laboratory protocols into therapies is explained in sections on basic science, clinical translation, regulatory, ethical and industrial issues. The textbook is aiming to give the student, the researcher, the health care professional, the physician, and the patient a complete survey on the current scientific basis, therapeutical protocols, clinical translation and practised therapies in Regenerative Medicine.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309455111 Total Pages :137 pages Book Rating :4.3/5 (94 download)
Book Synopsis Exploring the State of the Science in the Field of Regenerative Medicine by : National Academies of Sciences, Engineering, and Medicine
Download or read book Exploring the State of the Science in the Field of Regenerative Medicine written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-06-16 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regenerative medicine holds the potential to create living, functional cells and tissues that can be used to repair or replace those that have suffered potentially irreparable damage due to disease, age, traumatic injury, or genetic and congenital defects. The field of regenerative medicine is broad and includes research and development components of gene and cell therapies, tissue engineering, and non-biologic constructs. Although regenerative medicine has the potential to improve health and deliver economic benefits, this relatively new field faces challenges to developing policies and procedures to support the development of novel therapies are both safe and effective. In October 2016, the National Academies of Sciences, Engineering, and Medicine hosted a public workshop with the goal of developing a broad understanding of the opportunities and challenges associated with regenerative medicine cellular therapies and related technologies. Participants explored the state of the science of cell-based regenerative therapies within the larger context of patient care and policy. This publication summarizes the presentations and discussions from the workshop.
Download or read book The Explosion of Life Forms written by and published by John Wiley & Sons. This book was released on 2021-03-11 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: One of the essential characteristics of living beings is the explosion of variety in their forms that is intrinsically linked to the diversity of the environments they have adapted to. This book, the result of collaboration between international specialists, analyzes the multiplicity of these morphologies. It explores the origin of forms, their role in defining living things, and the relationship between form and function. It exposes the role of genes and epigenetics and examines the forms of bacteria, protists and plants. The Explosion of Life Forms also studies the memory of animals and their sensory processes, the forms of robots (built in the image of living things), and medical technologies aimed at restoring damaged living forms. Finally, this work questions a common principle of construction in the diversity of forms, as well as the idea of an abandonment of the form, a possible hidden defect of some modern philosophies.
Book Synopsis Biomedical Product Development: Bench to Bedside by : Babak Arjmand
Download or read book Biomedical Product Development: Bench to Bedside written by Babak Arjmand and published by Springer Nature. This book was released on 2020-02-05 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This textbook covers all the steps in manufacturing a biomedical product from bench to bedside. It specifically focuses on quality assurance and management and explains the different good practice principles in the various phases of product development as well as how to fulfill them: Good laboratory practice, good manufacturing practice and good clinical practice. It provides readers with the know-how to design biomedical experiments to ensure quality and integrity, to plan and conduct standard preclinical studies and to assure the quality of the final manufactured biomedical products. Importantly, it also addresses ethical concerns and considerations. The book discusses the guidelines and ethical considerations for preclinical and clinical studies, to allow readers to identify safety concerns regarding biomedical products and to improve pre-clinical studies for the development of better products. This textbook is a valuable guide for biomedical students (B.Sc., M.S., and Ph.D. students) in the field of molecular medicine, medical biotechnology, stem cell research and related areas, as well as for professionals such as quality control staff, tissue bankers, policy-makers and health professionals.
Author :Venkatram Prasad Shastri Publisher :Springer Science & Business Media ISBN 13 :9048187885 Total Pages :414 pages Book Rating :4.0/5 (481 download)
Book Synopsis Advances in Regenerative Medicine: Role of Nanotechnology, and Engineering Principles by : Venkatram Prasad Shastri
Download or read book Advances in Regenerative Medicine: Role of Nanotechnology, and Engineering Principles written by Venkatram Prasad Shastri and published by Springer Science & Business Media. This book was released on 2010-08-14 with total page 414 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book summarizes the NATO Advanced Research Workshop (ARW) on “Nanoengineered Systems for Regenerative Medicine” that was organized under the auspices of the NATO Security through Science Program. I would like to thank NATO for supporting this workshop via a grant to the co-directors. The objective of ARW was to explore the various facets of regenerative me- cine and to highlight role of the “the nano-length scale” and “nano-scale systems” in defining and controlling cell and tissue environments. The development of novel tissue regenerative strategies require the integration of new insights emerging from studies of cell-matrix interactions, cellular signalling processes, developmental and systems biology, into biomaterials design, via a systems approach. The chapters in the book, written by the leading experts in their respective disciplines, cover a wide spectrum of topics ranging from stem cell biology, developmental biology, ce- matrix interactions, and matrix biology to surface science, materials processing and drug delivery. We hope the contents of the book will provoke the readership into developing regenerative medicine paradigms that combine these facets into cli- cally translatable solutions. This NATO meeting would not have been successful without the timely help of Dr. Ulrike Shastri, Sanjeet Rangarajan and Ms. Sabine Benner, who assisted in the organization and implementation of various elements of this meeting. Thanks are also due Dr. Fausto Pedrazzini and Ms. Alison Trapp at NATO HQ (Brussels, Belgium). The commitment and persistence of Ms.
Book Synopsis Cardiac Regeneration by : Masaki Ieda
Download or read book Cardiac Regeneration written by Masaki Ieda and published by Springer. This book was released on 2017-10-27 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: This Volume of the series Cardiac and Vascular Biology offers a comprehensive and exciting, state-of-the-art work on the current options and potentials of cardiac regeneration and repair. Several techniques and approaches have been developed for heart failure repair: direct injection of cells, programming of scar tissue into functional myocardium, and tissue-engineered heart muscle support. The book introduces the rationale for these different approaches in cell-based heart regeneration and discusses the most important considerations for clinical translation. Expert authors discuss when, why, and how heart muscle can be salvaged. The book represents a valuable resource for stem cell researchers, cardiologists, bioengineers, and biomedical scientists studying cardiac function and regeneration.
Book Synopsis Stem Cell Therapies by : Adam C. Berger
Download or read book Stem Cell Therapies written by Adam C. Berger and published by National Academy Press. This book was released on 2014-06-18 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt: Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or else by supporting the body's intrinsic repair mechanisms, stem cells hold the potential to treat such debilitating conditions as Parkinson's disease, diabetes, and spinal cord injury. Clinical trials of stem cell treatments are under way in countries around the world, but the evidence base to support the medical use of stem cells remains limited. Despite this paucity of clinical evidence, consumer demand for treatments using stem cells has risen, driven in part by a lack of available treatment options for debilitating diseases as well as direct-to-consumer advertising and public portrayals of stem cell-based treatments. Clinics that offer stem cell therapies for a wide range of diseases and conditions have been established throughout the world, both in newly industrialized countries such as China, India, and Mexico and in developed countries such as the United States and various European nations. Though these therapies are often promoted as being established and effective, they generally have not received stringent regulatory oversight and have not been tested with rigorous trials designed to determine their safety and likely benefits. In the absence of substantiated claims, the potential for harm to patients - as well as to the field of stem cell research in general - may outweigh the potential benefits. To explore these issues, the Institute of Medicine, the National Academy of Sciences, and the International Society for Stem Cell Research held a workshop in November 2013. "Stem Cell Therapies" summarizes the workshop. Researchers, clinicians, patients, policy makers, and others from North America, Europe, and Asia met to examine the global pattern of treatments and products being offered, the range of patient experiences, and options to maximize the well-being of patients, either by protecting them from treatments that are dangerous or ineffective or by steering them toward treatments that are effective. This report discusses the current environment in which patients are receiving unregulated stem cell offerings, focusing on the treatments being offered and their risks and benefits. The report considers the evidence base for clinical application of stem cell technologies and ways to assure the quality of stem cell offerings.
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.
Book Synopsis Cell and Gene Therapies by : Miguel-Angel Perales
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 286 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.
Book Synopsis Regulatory Aspects of Gene Therapy and Cell Therapy Products by : Maria Cristina Galli
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.
