Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309466474
Category : Medical
Languages : en
Pages : 125
Get Book Here
Book Description
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: 9780309151825
Category : Medical
Languages : en
Pages : 170
Get Book Here
Book Description
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: 0309489121
Category : Medical
Languages : en
Pages : 133
Get Book Here
Book Description
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.
Author: Adrian P. Gee
Publisher: Springer Nature
ISBN: 3030755371
Category : Science
Languages : en
Pages : 681
Get Book Here
Book Description
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.
Author: Joan Oliva
Publisher: Frontiers Media SA
ISBN: 2889767701
Category : Science
Languages : en
Pages : 336
Get Book Here
Book Description
Author: Jorge S. Burns
Publisher: Springer Nature
ISBN: 3031300408
Category : Science
Languages : en
Pages : 226
Get Book Here
Book Description
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
Author:
Publisher: John Wiley & Sons
ISBN: 1119818435
Category : Science
Languages : en
Pages : 256
Get Book Here
Book Description
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.
Author: Venkatram Prasad Shastri
Publisher: Springer Science & Business Media
ISBN: 9048187885
Category : Technology & Engineering
Languages : en
Pages : 414
Get Book Here
Book Description
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.
Author: Adam C. Berger
Publisher: National Academy Press
ISBN: 9780309303002
Category : Medical
Languages : en
Pages : 108
Get Book Here
Book Description
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.
Author: Miguel-Angel Perales
Publisher: Springer
ISBN: 3319543687
Category : Medical
Languages : en
Pages : 288
Get Book Here
Book Description
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.
