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| autologous cell therapy manufacturing: Ex Vivo Cell Therapy Klaus Schindhelm, Robert Nordon, 1999 R.E. Nordon and K. Schindhelm, Introduction. -- L. Robb, A.G. Elefanty, and C.G. Begley, Transcriptional Control of Hematopoieses. -- R. Starr and N.A. Nicola, Cell Signaling by Hemopoietic Growth Factor Receptors. -- P.J. Simmons, D.N. Haylock, and J.-P. Lévesque, Influence of Cytokines and Adhesion Molecules on Hematopoietic Stem Cell Development. -- P.A. Rowlings, Allogeneic Hematopoietic Stem Cell Transplantation. -- U. Hahn and L.B. To, Autologous Stem Cell Transplantation. -- M.R. Vowels, Cord Blood Stem Cell Transplantation. -- S.R. Riddell, E.H. Warren, D. Lewinsohn, C. Yee, and P.D. Greenberg, Reconstitution of Immunity by Adoptive Immunotherapy with T Cells. -- L.Q. Sun, M. Miller, and G. Symonds, Exogenous Gene Transfer into Lymphoid and Hematopoietic Progenitor Cells. -- C. Dowding, T. Leemhuis, A. Jakubowski, and C. Reading, Process Development for Ex Vivo Cell Therapy. -- R.E. Nordon and K. Schindhelm, Cell Separation. -- P.W. Zandstra, C.J. Eaves, and J.M. Piret, Environ ... |
| autologous cell therapy manufacturing: The EBMT/EHA CAR-T Cell Handbook Nicolaus Kröger, John Gribben, Christian Chabannon, Ibrahim Yakoub-Agha, Hermann Einsele, 2022-02-07 This first open access European CAR-T Handbook, co-promoted by the European Society for Blood and Marrow Transplantation (EBMT) and the European Hematology Association (EHA), covers several aspects of CAR-T cell treatments, including the underlying biology, indications, management of side-effects, access and manufacturing issues. This book, written by leading experts in the field to enhance readers’ knowledge and practice skills, provides an unparalleled overview of the CAR-T cell technology and its application in clinical care, to enhance readers’ knowledge and practice skills. |
| autologous cell therapy manufacturing: Progenitor and Stem Cell Technologies and Therapies Anthony Atala, 2012-03-15 Progenitor and stem cells have the ability to renew themselves and change into a variety of specialised types, making them ideal materials for therapy and regenerative medicine. Progenitor and stem cell technologies and therapies reviews the range of progenitor and stem cells available and their therapeutic application.Part one reviews basic principles for the culture of stem cells before discussing technologies for particular cell types. These include human embryonic, induced pluripotent, amniotic and placental, cord and multipotent stem cells. Part two discusses wider issues such as intellectual property, regulation and commercialisation of stem cell technologies and therapies. The final part of the book considers the therapeutic use of stem and progenitor cells. Chapters review the use of adipose tissue-derived stem cells, umbilical cord blood (UCB) stem cells, bone marrow, auditory and oral cavity stem cells. Other chapters cover the use of stem cells in therapies in various clinical areas, including lung, cartilage, urologic, nerve and cardiac repair.With its distinguished editor and international team of contributors, Progenitor and stem cell technologies and therapies is a standard reference for both those researching in cell and tissue biology and engineering as well as medical practitioners investigating the therapeutic use of this important technology. - Reviews the range of progenitor and stem cells available and outlines their therapeutic application - Examines the basic principles for the culture of stem cells before discussing technologies for particular cell types, including human embryonic, induced pluripotent, amniotic and placental, cord and multipotent stem cells - Includes a discussion of wider issues such as intellectual property, regulation and commercialisation of stem cell technologies and therapies |
| autologous cell therapy manufacturing: Regulatory Aspects of Gene Therapy and Cell Therapy Products Maria Cristina Galli, Mercedes Serabian, 2015-09-15 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. |
| autologous cell therapy manufacturing: Single-Use Technology in Biopharmaceutical Manufacture Regine Eibl, Dieter Eibl, 2019-07-18 Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system. |
| autologous cell therapy manufacturing: Cell and Gene Therapies Miguel-Angel Perales, Syed A. Abutalib, Catherine Bollard, 2018-11-27 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. |
| autologous cell therapy manufacturing: The European Blood and Marrow Transplantation Textbook for Nurses Michelle Kenyon, Aleksandra Babic, 2018-03-14 This book is open access under a CC BY 4.0 license. This textbook, endorsed by the European Society for Blood and Marrow Transplantation (EBMT), provides adult and paediatric nurses with a full and informative guide covering all aspects of transplant nursing, from basic principles to advanced concepts. It takes the reader on a journey through the history of transplant nursing, including essential and progressive elements to help nurses improve their knowledge and benefit the patient experience, as well as a comprehensive introduction to research and auditing methods. This new volume specifically intended for nurses, complements the ESH-EBMT reference title, a popular educational resource originally developed in 2003 for physicians to accompany an annual training course also serving as an educational tool in its own right. This title is designed to develop the knowledge of nurses in transplantation. It is the first book of its kind specifically targeted at nurses in this specialist field and acknowledges the valuable contribution that nursing makes in this area. This volume presents information that is essential for the education of nurses new to transplantation, while also offering a valuable resource for more experienced nurses who wish to update their knowledge. |
| autologous cell therapy manufacturing: Bioprocessing for Cell-Based Therapies Che J. Connon, 2017-02-06 With contributions from leading, international academics and industrial practitioners, Bioprocessing for Cell-Based Therapies explores the very latest techniques and guidelines in bioprocess production to meet safety, regulatory and ethical requirements, for the production of therapeutic cells, including stem cells. An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout In depth discussion of the application of cell therapy including methods used in the delivery of cells to the patient Includes contributions from experts in both academia and industry, combining a practical approach with cutting edge research The only handbook currently available to provide a state of the art guide to Bioprocessing covering the complete range of cell-based therapies, from experts in academia and industry |
| autologous cell therapy manufacturing: Mesenchymal Stem Cell Therapy Lucas G. Chase, Mohan C Vemuri, 2012-12-12 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. |
| autologous cell therapy manufacturing: Translational Regenerative Medicine Anthony Atala, Julie Allickson, 2014-12-01 Translational Regenerative Medicine is a reference book that outlines the life cycle for effective implementation of discoveries in the dynamic field of regenerative medicine. By addressing science, technology, development, regulatory, manufacturing, intellectual property, investment, financial, and clinical aspects of the field, this work takes a holistic look at the translation of science and disseminates knowledge for practical use of regenerative medicine tools, therapeutics, and diagnostics. Incorporating contributions from leaders in the fields of translational science across academia, industry, and government, this book establishes a more fluid transition for rapid translation of research to enhance human health and well-being. - Provides formulaic coverage of the landscape, process development, manufacturing, challenges, evaluation, and regulatory aspects of the most promising regenerative medicine clinical applications - Covers clinical aspects of regenerative medicine related to skin, cartilage, tendons, ligaments, joints, bone, fat, muscle, vascular system, hematopoietic /immune system, peripheral nerve, central nervous system, endocrine system, ophthalmic system, auditory system, oral system, respiratory system, cardiac system, renal system, hepatic system, gastrointestinal system, genitourinary system - Identifies effective, proven tools and metrics to identify and pursue clinical and commercial regenerative medicine |
| autologous cell therapy manufacturing: Cell Therapy Adrian Gee, 2009-09-18 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. |
| autologous cell therapy manufacturing: Living Donor Transplantation Henkie P. Tan, Amadeo Marcos, Ron Shapiro, 2007-04-27 Edited by leaders at one of the acclaimed transplant institutions in the United States, this reference covers all aspects of living donor solid organ and cellular transplantation in current clinical practice, including the kidney, liver, pancreas, lung, small bowel, islet, and hematopoietic stem cell transplantation. Detailed, engaging, and organ- |
| autologous cell therapy manufacturing: Stem Cells and the Future of Regenerative Medicine Institute of Medicine, Board on Neuroscience and Behavioral Health, National Research Council, Division on Earth and Life Studies, Board on Life Sciences, Committee on the Biological and Biomedical Applications of Stem Cell Research, 2002-01-25 Recent scientific breakthroughs, celebrity patient advocates, and conflicting religious beliefs have come together to bring the state of stem cell researchâ€specifically embryonic stem cell researchâ€into the political crosshairs. President Bush's watershed policy statement allows federal funding for embryonic stem cell research but only on a limited number of stem cell lines. Millions of Americans could be affected by the continuing political debate among policymakers and the public. Stem Cells and the Future of Regenerative Medicine provides a deeper exploration of the biological, ethical, and funding questions prompted by the therapeutic potential of undifferentiated human cells. In terms accessible to lay readers, the book summarizes what we know about adult and embryonic stem cells and discusses how to go about the transition from mouse studies to research that has therapeutic implications for people. Perhaps most important, Stem Cells and the Future of Regenerative Medicine also provides an overview of the moral and ethical problems that arise from the use of embryonic stem cells. This timely book compares the impact of public and private research funding and discusses approaches to appropriate research oversight. Based on the insights of leading scientists, ethicists, and other authorities, the book offers authoritative recommendations regarding the use of existing stem cell lines versus new lines in research, the important role of the federal government in this field of research, and other fundamental issues. |
| autologous cell therapy manufacturing: Stem Cell Manufacturing Joaquim M.S. Cabral, Claudia Lobato da Silva, Lucas G. Chase, M. Margardia Diogo, 2016-07-24 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 |
| autologous cell therapy manufacturing: Quality Management and Accreditation in Hematopoietic Stem Cell Transplantation and Cellular Therapy Mahmoud Aljurf, John A. Snowden, Patrick Hayden, Kim H. Orchard, Eoin McGrath, 2021-02-19 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. |
| autologous cell therapy manufacturing: Methods of Tissue Engineering Anthony Atala, Robert Lanza, 2001-10-12 This reference book combines the tools, experimental protocols, detailed descriptions and know-how for the successful engineering of tissues and organs in one volume. |
| autologous cell therapy manufacturing: Therapeutic Oligonucleotides Jens Kurreck, 2008 This book provides a compelling overall update on current status of RNA interference |
| autologous cell therapy manufacturing: Wound Healing Biomaterials - Volume 1 Magnus Ågren, 2016-06-03 Wound Healing Biomaterials: Volume One, Therapies and Regeneration discusses the types of wounds associated with trauma, illness, or surgery that can sometimes be extremely complex and difficult to heal. Consequently, there is a prominent drive for scientists and clinicians to find methods to heal these types of wounds, with science increasingly turning towards biomaterials to address these challenges. Much research is now concerned with new therapies, regeneration methods, and biomaterials to assist in wound healing and healing response. This book provides readers with a comprehensive review of the fundamentals and advances in the field of wound healing with regard to therapies and tissue regeneration. Chapters in Part One discuss fundamentals and strategies of wound healing, while Part Two reviews gene, stem cell, and drug delivery therapies for wound healing. Final chapters look at tissue regeneration strategies, making this an all-encompassing book on the topic of wound care and biomaterials. - Provides more systematic and comprehensive coverage of specific therapies and biomaterials for wound healing - Highlights research that is concerned with new therapies, regeneration methods, and the use of biomaterials to assist in wound healing and healing response - Presents an organized layout of the material that is carefully arranged with clear titles and comprehensive section headings - Looks at tissue regeneration strategies, making this an all encompassing book on the topic of wound care |
| autologous cell therapy manufacturing: Exploring Novel Clinical Trial Designs for Gene-Based Therapies National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Board on Health Sciences Policy, Forum on Regenerative Medicine, 2020-08-27 Recognizing the potential design complexities and ethical issues associated with clinical trials for gene therapies, the Forum on Regenerative Medicine of the National Academies of Sciences, Engineering, and Medicine held a 1-day workshop in Washington, DC, on November 13, 2019. Speakers at the workshop discussed patient recruitment and selection for gene-based clinical trials, explored how the safety of new therapies is assessed, reviewed the challenges involving dose escalation, and spoke about ethical issues such as informed consent and the role of clinicians in recommending trials as options to their patients. The workshop also included discussions of topics related to gene therapies in the context of other available and potentially curative treatments, such as bone marrow transplantation for hemoglobinopathies. This publication summarizes the presentation and discussion of the workshop. |
| autologous cell therapy manufacturing: Stem Cells in Clinical Practice and Tissue Engineering Rakesh Sharma, 2018-05-02 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. |
| autologous cell therapy manufacturing: Human Embryonic Stem Cells Arlene Chiu, Mahendra S. Rao, 2003-08 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. |
| autologous cell therapy manufacturing: Haploidentical Transplantation Stefan O. Ciurea, Rupert Handgretinger, 2018-05-03 In this book, world-renowned experts in the field express well-reasoned opinions on a range of issues and controversies relating to haploidentical transplantation with the aim of providing practicing hematologists with clinically relevant and readily applicable information. Among the areas covered are graft manipulation and methods to control T-cell alloreactivity, the nature of the ideal graft and donor, haploidentical transplantation in pediatric and adult patients with malignant and nonmalignant diseases, immunologic reconstitution following transplantation, complications, and the prevention and treatment of relapse post transplantation. Attention is drawn to the implications of high-impact clinical trials whenever such trials are available. The readily intelligible text is complemented by numerous helpful tables, algorithms, and figures. The book will provide practical support for hematologists and transplant physicians as they attempt to provide optimal care in this exciting but increasingly complex medical specialty. |
| autologous cell therapy manufacturing: Advances In Pharmaceutical Cell Therapy: Principles Of Cell-based Biopharmaceuticals Christine Guenther, Andrea Josefine Hauser, Ralf Huss, 2015-09-23 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. |
| autologous cell therapy manufacturing: Stem Cell Therapies Adam C. Berger, Sarah H. Beachy, Board on Health Sciences Policy, Steve Olson, Board on Life Sciences, Division on Earth and Life Sciences, Institute of Medicine, National Academy of Sciences, 2014-06-18 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. |
| autologous cell therapy manufacturing: Oncoimmunology Laurence Zitvogel, Guido Kroemer, 2017-12-13 In this book, leading experts in cancer immunotherapy join forces to provide a comprehensive guide that sets out the main principles of oncoimmunology and examines the latest advances and their implications for clinical practice, focusing in particular on drugs with FDA/EMA approvals and breakthrough status. The aim is to deliver a landmark educational tool that will serve as the definitive reference for MD and PhD students while also meeting the needs of established researchers and healthcare professionals. Immunotherapy-based approaches are now inducing long-lasting clinical responses across multiple histological types of neoplasia, in previously difficult-to-treat metastatic cancers. The future challenges for oncologists are to understand and exploit the cellular and molecular components of complex immune networks, to optimize combinatorial regimens, to avoid immune-related side effects, and to plan immunomonitoring studies for biomarker discovery. The editors hope that this book will guide future and established health professionals toward the effective application of cancer immunology and immunotherapy and contribute significantly to further progress in the field. |
| autologous cell therapy manufacturing: Usp38-Nf33 United States Pharmacopeial Convention, 2014-11-01 |
| autologous cell therapy manufacturing: Cells Are the New Cure Robin L. Smith, 2017-10-24 The future of medicine is happening now. Revolutionary new science is providing cures that were considered science fiction just a few years ago—and not with pills, surgery, or radiation, but with human cells. Promising treatments now in extensive clinical trials could have dramatic impacts on cancer, autoimmune diseases, organ replacement, heart disease, and even aging itself. The key to these breakthroughs is the use of living cells as medicine instead of traditional drugs. Discover the advances that are alleviating the effects of strokes, Alzheimer's disease, and even allergies. Cells Are the New Cure takes you into the world of regenerative medicine, which enables doctors to repair injured and aging tissues and even create artificial body parts and organs in the lab. Cellular medicine experts Robin L. Smith, MD, and Max Gomez, PhD, outline the new technologies that make it possible to harness the immune system to fight cancer and reverse autoimmune diseases like multiple sclerosis, type 1 diabetes, and rheumatoid arthritis. CRISPR, a new technology for targeted gene editing, promises to eradicate genetic diseases, allowing us to live longer lives—possibly even beyond age 100 in good health. Cells Are the New Cure takes you on a tour of the most exciting and cutting-edge developments in medicine. The content inside these pages could save your life or the life of someone you love. |
| autologous cell therapy manufacturing: Stem Cells and Cell Therapy Mohamed Al-Rubeai, Mariam Naciri, 2013-10-01 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. |
| autologous cell therapy manufacturing: Splicing Life United States. President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1982 |
| autologous cell therapy manufacturing: Perinatal Stem Cells Anthony Atala, Kyle J. Cetrulo, Rouzbeh R. Taghizadeh, Curtis L Cetrulo, Sean Murphy, 2018-06-14 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 |
| autologous cell therapy manufacturing: The Management of Clinical Trials Hesham Abdeldayem, 2018-06-06 This concise book is addressed to researchers, clinical investigators, as well as practicing physicians and surgeons who are interested in the fields of clinical research and trials. It covers some important topics related to clinical trials including an introduction to clinical trials, some aspects concerning clinical trials in pediatric age group, and the unique aspects of the design of clinical trials on stem cell therapy. |
| autologous cell therapy manufacturing: Therapy with Cultured Cells Howard Green, 2019-05-08 In this book the author describes the discoveries in his laboratory that led to therapy with cultured cells. The first cultured cell type used for therapy was the keratinocyte of the epidermis, for the treatment of burns. Subsequent developments led to the use of cultured cells for the treatment of diseases of the eye, of the joints and of other diseases. Cultured cells for therapy are now being prepared by industries in the US, Japan and Korea and are used in the aforesaid countries, as well as in France, Sweden and Greece, for the treatment of disease. |
| autologous cell therapy manufacturing: Advances in Precision Medicine Oncology Hilal Arnouk, Bassam Abdul Rasool Hassan, 2021 Recent advances in precision medicine and immuno-oncology have led to highly specific and efficacious cancer therapies such as monoclonal antibodies and immune checkpoint inhibitors (ICIs). This book provides an up-to-date overview of advances in the field of immuno-oncology. Chapters cover such topics as ICIs and how they mount a robust immune response against cancer cells as well as the response of ICIs to treatment predictive biomarkers and their potential immune-related adverse events (irAEs). Additionally, the book includes a comprehensive review of the powerful FDA-approved therapeutic agent doxorubicin, highlighting the molecular mechanisms behind doxorubicin's drug resistance and critical side effects. |
| autologous cell therapy manufacturing: Living Donor Organ Transplantation Rainer W.G. Gruessner, Enrico Benedetti, 2024-01-22 Living Organ Donor Transplantation, Second Edition puts the entire discipline in perspective while guiding readers step-by-step through the most common organ transplant surgeries. Organized into four cohesive parts and featuring numerous surgical illustrations, this sourcebook delivers an incisive look at every key consideration for general surgeons who perform transplantations, from patient selection to recipient workup and outcomes, and emphasizes the most humanitarian approaches. Sections provide content on living donor uterus transplantation, new operative techniques, including the use of robotic and minimally invasive transplant procedures, new immunosuppressive regimens, new protocols of tolerance induction including stem cell therapy and transplantation, and much more.Chapter authors are international leaders in their fields and represent institutions from four continents (Americas: USA, Argentina, Brazil, Canada; Europe: France, Germany, Italy, Spain, Sweden, UK; Asia: China, Japan, Korea, Taiwan; Australia). - Provides an A-Z, operation-oriented guide to the field of living donor organ transplantation - Examines a wide spectrum of solid organ transplantation procedures (liver, pancreas, kidney, intestine), with accompanying chapters on the history of the procedure, the donor, the recipient, and cost analysis - Covers techniques that explain adequate pretransplant workup and posttransplant care - Covers cultural differences, ethical and legal issues, social issues, current financial incentives, and the illegal organ trade |
| autologous cell therapy manufacturing: Phase Appropriate GMP for Biological Processes Trevor Deeks, 2018-04 |
| autologous cell therapy manufacturing: Current Strategies in Cancer Gene Therapy Wolfgang Walther, 2017-01-17 This book describes important developments and emerging trends in experimental and clinical cancer gene therapy. It reflects the tremendous advances made over recent years with respect to immunogenes, suicide genes and gene correction therapies, as well as in gene suppression and miRNA therapies. Many of the described strategies focus on the generation of more efficient and specific means of attack at known and novel cellular targets associated with tumor development and progression. The book also details parallel improvements in vector design, vector delivery, and therapeutic efficacy. It offers readers a stimulating, broad overview of advances in the field, linking experimental strategies to their clinical applications. |
| autologous cell therapy manufacturing: Stem Cells Mariusz Z. Ratajczak, 2020-01-02 Since different types of stem cells for therapeutic applications have recently been proposed, this timely volume explores various sources of stem cells for tissue and organ regeneration and discusses their advantages and limitations. Also discussed are pros and cons for using embryonic stem cells, induced pluripotent stem cells, and adult stem cells isolated from postnatal tissues. Different types of adult stem cells for therapeutic applications are also reviewed, including hematopoietic stem cells, epidermal stem cells, endothelial progenitors, neural stem cells, mesenchymal stem cells, and very small embryonic-like stem cells. This book also addresses paracrine effects of stem cells in regenerative medicine that are mediated by extracellular microvesicles and soluble secretome. Finally, potential applications of stem cells in cardiology, gastroenterology, neurology, immunotherapy, and aging are presented. This is an ideal book for students and researchers working in the stem cell research field. |
| autologous cell therapy manufacturing: Allocation of Staff , 1983 |
| autologous cell therapy manufacturing: Stem Cells – From Hype to Real Hope Khawaja Husnain Haider, Salim Aziz, MD, 2018-12-17 This book is a compilation of the bench experience of leading experts from various research labs involved in the cutting edge area of research. The authors describe the use of stem cells both as part of the combinatorial therapeutic intervention approach and as tools (disease model) during drug development, highlighting the shift from a conventional symptomatic treatment strategy to addressing the root cause of the disease process. The book is a continuum of the previously published book entitled Stem Cells: from Drug to Drug Discovery which was published in 2017. |
| autologous cell therapy manufacturing: Organ Manufacturing Xiaohong Wang, 2015 This is the first time that human organs, such as the heart, liver, kidney, stomach, uterus, skin, lung, pancreas and breast can be manufactured automatically and precisely for clinical transplantation, drug screening and metabolism model establishment. Headed by Professor Xiaohong Wang (also the founder and director) in the Center of Organ Manufacturing, Department of Mechanical Engineering, Tsinghua University, this group has focused on organ manufacturing for over ten years. A series of technical bottleneck problems, such as vascular and nerve system establishment in a construct, multiple cell types and material system incorporation, and stem cell sequential engagement, have been overcome one by one. Two technical approaches have been exploited extensively. One is multiple nozzle rapid prototyping (RP), additive manufacturing (AM), or three-dimension (3D) printing. The other is combined mold systems. More than 110 articles and 40 patents with a series of theories and practices have been published consequently. In the future, all the failed organs (including the brain) in the human body can be substituted easily like a small accessory part in a car. Everyone can get benefit from these techniques, which ultimately means that the lifespan of humans, therefore, can be greatly prolonged from this time point. This book examines the progress made in the field and the developments made by these researchers (and authors) in the field. |
Development of an automated manufacturing process for
In this article, we describe the results of a strategic alliance between GSK and Miltenyi Biotec to develop a closed, automated manufacturing process using the CliniMACS Prodigy for autologous …
Centralized vs Decentralized Manufacturing of Personalized …
All of the cancer cell therapies on the market, and a majority of clinical assets (about 75 percent) are autologousii, meaning the cell therapy treats the same individual from whom these cells are …
Autologous Cell Therapy: Key Challenges and Bioprocessing …
Autologous cell therapy — isolating, engineering and expanding a patient’s own cells and reintroducing them to combat disease — is an emerging modality that has garnered significant …
End-to-end manufacturing of autologous CAR T cell therapies …
Here we present an end-to-end solution for autologous CAR T cell therapy manufacturing, using our new modular, and digitally integrated platform, that consists of two functionally closed systems: • …
Autologous CAR T cell manufacturing using a semiautomatic, …
Autologous CAR T cell therapies are donor-specific, where a donor’s own immune cells are used to create therapeutic CAR T (Figure 1A).
BMS cell therapy operations and manufacturing
Bristol Myers Squibb is advancing the field of cell therapy through novel manufacturing approaches and a well-established supply chain platform across a broad network of state-of-the …
MANUFACTURING PROCESS IMPROVEMENT FOR SCALE UP …
manufacturing processes for rare cell types is critical for the success of autologous therapies. Historical methods employ a modular approach in which a combination of systems are utilized to …
Time, Logistics, And Manufacturing In Autologous Cell Therapy …
Standardization in manufacturing serves to reduce raw material shortages and de-risk the manufac-turing process (i.e., modification and expansion of cells), as well as improve GMP batch record …
Platforms for Manufacturing Allogeneic, Autologous and iPSC …
Here we give an overview of the platforms and technologies currently available to manufacture allogeneic cell products, such as mesenchymal stem cells (MSCs) and induced pluripotent stem …
Manufacturing innovation to drive down cell therapy costs
first-generation autologous CAR-T manufacturing, five major drivers of innovation have emerged: vector innovation, process improvements, hardware improvements, digital innovations, and point …
Stability Considerations and Challenges in Autologous Cell …
Jun 10, 2019 · Stability considerations for autologous cell therapy products are complex • Rapid development timelines may reduce “phase appropriate” stability strategies • Stability methods …
AUTOLOGOUS CELL THERAPY MANUFACTURING - Takeda
The engineered autologous cell therapy must be quickly delivered back to the individual patient for treatment. This autologous manufacturing process needs to be repeated for each individual …
COGs process economics for autologous cell therapy - Cytiva
But, in order to widen access to these life-saving autologous cell therapy treatments, it’s crucial that manufacturers utilize solutions that can support reductions in labor and material costs.
Development of a robotic cluster for automated and scalable …
Here, we describe the performance of a new prototype robotic sys-tem designed to operate industry-standard cell therapy manufacturing equipment. We robotically automate the culture of …
An automated 24-hour CAR-T manufacturing pocess
This article presents an automated and shortened leniviral-based CAR-T workflow using the GibcoTM CTSTM Detachable DynabeadsTM CD3/CD28 magnetic beads, GibcoTM CTSTM …
Evolving autologous and allogeneic cell therapy manufacturing …
CELL THERAPY S 830 DOI: 10.18609/cgti.2020.095 Q What is your organization’s current manufacturing model, and how might it change as you get closer to commercialization? GR: …
A Novel Approach for Accelerated Development of CAR-T …
Automated T-cell isolation methods, including density gradient separation and magnetic T-cell selection, are favored in clinical settings for their effectiveness in minimizing contamination risks …
A simulation-based comparison of centralized and point-of …
Autologous cell therapy (AuCT) is an emerging field of medicine that offers significant promise for the treatment of a variety of dis-eases [1,2]. However, with the growing demand for AuCT …
An Innovative Approach Towards Standardizing Cell Therapy …
For treatments such as autologous CAR-T cell therapy that use an individual patient’s cells, there is an inherent variability built into the process. Therefore, any solutions that support cell therapy …
FROM AUTOLOGOUS CELL BANKING TO ALLOGENEIC CELL …
The upgraded process, transitioning from an autologous cell bank to an allogeneic cell therapy manufacturing facility, is driven by a carefully designed CMC strategy.
Considerations for the development of iPSC-derived cell …
criteria, the process of all iPSC-derived cell therapy manufacturing begins with a somatic cell type. This somatic cell is then reprog-rammed, typically via delivery of the Yamanaka or Thomson …
Regulatory considerations for developing a phase I …
potential. Despite manufacturing challenges, autologous iPSC-based cell therapies are being tested for various dis-eases. Clinical data from autologous stem cell therapies have suggested …
Overcoming ex vivo cell therapy manufacturing challenges …
Figure 1: The difference in time to treatment between autologous and allogeneic ex vivo vs. in vivo CAR T-cell therapies.2,3 Ship PBMCs To facility Ship CAR T-cells To hospital Figure 2:The …
Decentralized manufacturing: Unlocking CAR-T’s potential - ZS
autologous CAR-T therapy could be as high as $250,000-$380,000 per batch. This is because 30%-35% of a therapy’s costs, which include asset depreciation, IT, order management ...
Treg cell therapy manufacturability: current state - Frontiers
manufacturing Autologous Treg Cell Therapy is a type of immunotherapy that involves isolating and expanding Treg cells from a patient’s own immune system to treat various autoimmune …
Development of a robotic cluster for automated and scalable …
autologous cell therapy automated manufacturing CD8+ T cells functionally closed system Industry 4.0 pilot robotic system Introduction Cell and gene therapies are expensive to develop …
Cellular Therapy Products - U.S. Food and Drug Administration
Manufacturing of cellular therapies is reviewed in the Division of Cell and Gene ... somatic cell therapy is defined as any autologous, allogeneic, or xenogeneic cells
Manufacturing models permitting roll out/scale out of …
and seek input from key stakeholders active in the field of autologous cell therapy in establishing a consensus-based manufacturing approach that may permit the roll out of clinically led …
Autologous, Allogeneic CAR T, and the New Frontiers of CAR …
For the autologous cell therapy (ACT), the testing strategy has to assure the good recovery of T cells from apheresis checking the total cell number after isolation, cell functionality, viability, …
Direct in vivo CAR T cell engineering - Cell Press
Jan 24, 2024 · Ex vivo manufacture of patient-specific CAR T cell product begins at patient referral. - Complex, expensive, and time-consuming manufacturing process for autologous cell …
Generation of QTPP, Risk Assessment, and CQA Identification …
In autologous cell therapies, CAR or TCR expression can be used for identity testing. At early clinical stages, CAR or TCR expression can also be used as a surrogate for potency. ... Raw …
FDA Perspective on Aseptic Process Simulation for Cell …
Cell Therapy Products – Unique Considerations • Highly product-specific manufacturing processes with inherent variability. −. Allogeneic vs. autologous therapies. −. Cryopreserved …
Sterile Fluid Transfer for Cell Therapy Manufacturing The …
autologous cell therapy manufacturing, it needs to be signi ficantly miniaturised and this can be challenging. NEW STERILE FLUID TRANSFER DEVICE: MULTIPLE-USE ASEPTIC …
Statistical Perspectives on Analytical Comparability Studies for ...
Ashton, Roland, et al. “Variance Components Analysis for Autologous Therapy Process Development”, Cell & Gene Therapy Products (CGTP), Bethesda (10 to 12 June 2019). 2. …
The CD19 CAR T-cell Therapy Journey - accc-cancer.org
Median manufacturing time: 17-28 days. Patients undergo lymphodepleting (and possibly salvage/bridging) therapy. Majors. EHA 2018. Abstr PS1156. ... Autologous CAR T-Cell …
Manufacturing Cell Therapies: The Paradigm Shift in Health …
of interest in cell-therapy manufacturing, as issues of cell viability, functionality, and patient safety become increasingly important to resolve as more therapies reach the market. For autologous …
Enabling Decentralized Manufacturing of Autologous …
Other pain points in manufacturing autologous ATMPs are the logistics involved in transporting the patient material to the manufacturing site and back to the patient. Key risk factors include ...
Robust and scalable GMP manufacturing of chondrocyte cell …
Cell Therapy Cell therapy involves injecting or implanting live cells to replace damaged tissue and restore lost function.[1] Autologous cell therapies make use of the patient’s own cells to …
Advanced Therapies Medicinal Products (ATMPs) CoP
• Phase appropriate CMC development strategy to improve the success rate of cell/gene therapy manufacturing and regulatory filings in both early and late development stages. Connecting …
Manufacturing of Gene Therapies: Ensuring Product Safety …
For cells and cell substrates used in the production of gene therapy products, the requirements are similar to those that would be asked for any biologic production systems.
Regulatory Knowledge Guide for Cell and Gene Therapies
therapies. (See the specific CAR T -cell resources listed below.) If your product is a CAR T -cell, it’s important to know the FDA f ramework for biological products regulates CAR -T cells as …
Autologous Cell Therapy Manufacturing - shaqqa.com
P6: Quality and Manufacturing Challenges in Cell and Gene Therapy Heather Francis, MSE 2 Challenges unique to autologous cell therapy manufacturing 3 One product lot results in one …
Autologous Cell Therapy Manufacturing (2024)
Autologous Cell Therapy Manufacturing: Cell Therapy Adrian Gee,2009-09-18 Cell Therapy cGMP Facilities and Manufacturing is the source for a complete discussion of facility design …
Robust Pre-Clinical Results and Large-Scale Manufacturing …
Process for EDIT-301: An Autologous Cell Therapy for the Potential Treatment of SCD Edouard De Dreuzy, 1Jack Heath, 1Patricia Sousa, Tusneem Janoudi, ... To evaluate the edited CD34+ …
Time, Logistics, And Manufacturing In Autologous Cell …
and the infrastructure required for autologous cell therapy (particularly as part of manufacturing scale-out) would be key to this effort. Similarly, training for individuals in the chemistry, man …
A multiscale simulation framework for the manufacturing …
Key Words: autologous cell therapy, cell manufacturing, multiscale simulation framework, supply chain Introduction Autologous cell therapy (AuCT) is an emerging ther-apeutic method that …
CAR-T cell manufacturing: Major process parameters and …
Sep 3, 2023 · REVIEW Cancer Focus CAR-Tcellmanufacturing:Majorprocessparameters and next-generation strategies Melanie Ayala Ceja1 , Mobina Khericha1* , Caitlin M. Harris1* , …
CMC Challenges for Accelerated Development of Human Cell …
CASSS Cell and Gene Therapy Products: Manufacturing, Quality and Regulatory Considerations. June 8, 2020. 2 Diversity of Cell & Gene Therapy (CGT) Products www.fda.gov ... Autologous …
Defining Microbial Control Strategies for cell-free and cell …
Cell therapy manufacturing is an E2E aseptic process Complex manual operations Autologous T cell therapy manufacturing can use starting material from patients which is not sterile (intrinsic …
Advances in Universal CAR-T Cell Therapy - Frontiers
Oct 7, 2021 · Nevertheless, some limitations persist in autologous CAR-T cell therapy, such as high costs, long manufacturing periods, and restricted cell sources. The development of a …
DEVELOPMENT OF INGENUI-T, A RAPID AUTOLOGOUS …
Background & Aim: Apheresis procedures in CAR T-cell therapy are costly, burdensome to patients and create bottlenecks due to the resources required. Traditional CAR T-cell …
A Monte Carlo framework for managing biological …
of a cell therapy needs to be sufficiently robust to the biological vari-ability of the input material to consistently generate cells that meet the required target product profile compatible with …
Development of an automated manufacturing process for
Original Article Development of an automated manufacturing process for large-scale production of autologous T cell therapies Natalie Francis,1 ,3Marion Braun, 2Sarah Neagle,1 Sabine …
DECIDE-ET
Autologous cell therapy has proven to be a durable treatment. Academic Medical Centers (AMCs) are unable to cost- ... costs for cell therapy manufacturing. Regulation ~5000 identified rare …
Transition from manual to automated processes for …
Keywords T cell therapy, Cell manufacturing, Automation, Cell expansion, Bioreactor, Process transfer While the use of adoptive T cell therapy for cancer treatment has been in research for …
AUTOLOGOUS CELL THERAPY MANUFACTURING - Takeda
The autologous cell therapy is administered back to the same patient. The patient’s cells are engineered in a weeks’ long process at an o˚site facility. The engineered autologous cell …
Cell Therapy - Bristol Myers Squibb
Autologous CAR T cell therapy • Autologous CAR T cell therapy involves using a patient’s own cells to start a highly sophisticated and personalized manufacturing process. • The complexity …
OVERCOMING CELL THERAPY MANUFACTURING …
autologous T-cell therapy workflow OVERCOMING CELL THERAPY MANUFACTURING CHALLENGES WITH CLOSED, MODULAR AND AUTOMATED SOLUTIONS …
Challenges and Lessons Learned in Autologous CAR T-Cell …
•Autologous cell therapy manufacturing (each patient is a lot, variability in vein-to-vein time, potential failure, bridging therapy considerations) •Large amount of data collected per patients …
Table of Contents - ISPE
Title: ISPE Guide: ATMPs Autologous Cell Therapy -- Table of Contents Author: ISPE Created Date: 11/29/2021 6:17:52 PM
Sefia Select system - Cytiva
a comprehensive solution to your cell processing needs. The automated and functionally closed system covers cell isolation, cell harvesting, and formulation resulting in a standardized …
A multiscale simulation framework for the manufacturing …
Key Words: autologous cell therapy, cell manufacturing, multiscale simulation framework, supply chain Introduction Autologous cell therapy (AuCT) is an emerging ther-apeutic method that …
The Importance of Closed Processes in Manufacturing and …
Two innovative forms of T‑cell therapy are at the forefront of this research: Chimeric Antigen Receptor T‑cell (CAR‑T) therapy and T‑cell Receptor (TCR) therapy. Historically, CAR‑T …
GUIDE: Advanced Therapy
Autologous Cell Therapy. Disclaimer: This Guide is intended to assist with manufacturing facilities development and design for producing autologous cell . therapies. This Guide is solely created …
Autologous cryopreserved leukapheresis cellular material …
CAR-T cell manufacturing technology using autol-ogous T cells for individualized cancer therapy is fun-damentally different from previous biological therapies and presents unique challenges. …
Transforming Cell & Gene Therapy Manufacturing White …
ene Therapy Cell mmuno-Oncology O Cell Therapy Tissue ngineering Data source: Alliance for Regenerative Medicine2 But despite tremendous advances and unprecedented growth, …
Overcoming the Challenges of Cell Therapy Manufacturing
cell collection with large-scale batch production runs helps decrease the cost of labor, offering a less expensive, time-saving, off-the-shelf solution to cell therapy. Taken together, the …
Manufacturing feedback loops for autologous, gene …
QUELL is leading the Treg cell therapy field with the potential for disease resolution with a single dose of CAR-Tregs Quell CAR-Treg Cell Therapy │ Durable, Dynamic Control of
Challenges in Commercialization of Autologous Cell Therapy …
Aspects Unique to Autologous Cell Therapy: Supply 4 Challenges • One patient is one lot (just in time manufacturing) • Patient specific product lot • Cell therapy is a new industry …
Early Stage CMC considerations for Source Materials and …
Jan 22, 2019 · Allogeneic Cell Therapies using Cell Banks. Autologous Cell Therapies or. Single Patient Allogeneic Therapies. 10 Further . Processing • Cell banks may provide source cells for …
