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| cell therapy quality control: 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. |
| cell therapy quality control: 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. |
| cell therapy quality control: 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 ... |
| cell therapy quality control: 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. |
| cell therapy quality control: 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. |
| cell therapy quality control: 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 |
| cell therapy quality control: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert, 2019-05-08 Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals. |
| cell therapy quality control: Cellular Therapy Ellen M. Areman, Kathy Loper, 2009 |
| cell therapy quality control: 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. |
| cell therapy quality control: 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. |
| cell therapy quality control: 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. |
| cell therapy quality control: 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. |
| cell therapy quality control: 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. |
| cell therapy quality control: 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. |
| cell therapy quality control: Mesenchymal Stem Cells Darwin J. Prockop, Donald G. Phinney, Bruce A. Bunnell, 2008-03-07 For over forty years, mesenchymal stem cells (MSCs) have been scrutinized and studied, garnering much attention due to their broad therapeutic efficacy. In this essential book, leaders in the field were assembled to contribute detailed methodologies for the isolation and characterization of human and rodent MSCs. Cutting edge and easy to use, this book is the perfect resource for scientists attempting to pursue this important and ever-developing field of research. |
| cell therapy quality control: Stem Cell Protocols Ivan N. Rich, 2014-11-11 This volume presents up-to-date methods that allow primary stem cells from a variety of sources to be isolated, cultured in vitro, detected and measured for specific applications. These applications range from those in basic, stem cell and veterinary research to toxicology, cellular therapy and regenerative medicine. There is a slight bias towards the blood-forming system as more is known about the blood-forming or hematopoietic system than any other primary stem cell system. These unique properties and characteristics are discussed and examined, mostly at the cellular level and in detail in this book. Written in the successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and accessible, Stem Cell Protocols provides novices with the fundamentals necessary to develop new technologies necessary for basic and clinical research in the future, and will aid professionals in finding new methodologies to provide a wider viewpoint and an even greater scope for their own research. |
| cell therapy quality control: Quality Control and Regulatory Aspects for Biologicals Gauri Misra, 2024-04-22 This book serves as a comprehensive guide on quality control and regulatory aspects for biological products. It covers a wide range of topics, including regulatory requirements, quality control strategies, analytical methods, and risk management. It delves into the advantages and limitations of in vivo tests and discusses alternative methods that can be employed. The book explores the use of animal-based testing methods in quality control and examines viable alternatives. Key Features: Reviews various scientific and regulatory aspects involved in the quality control of biologicals Provides an overview of the roles of various national and international regulatory bodies and accreditation agencies Presents advanced analytical methods, innovative technologies, and the integration of molecular diagnostics in quality control processes Explores the use of animal-based testing methods in quality control, as well as their alternatives Discusses guidelines and methodologies involved in the development of biological products Overall, this book is an important reference source for various professionals in the pharmaceutical industry, including researchers, scientists, quality control personnel, and regulatory affairs professionals. |
| cell therapy quality control: Video Bioinformatics Bir Bhanu, Prue Talbot, 2015-12-16 The advances of live cell video imaging and high-throughput technologies for functional and chemical genomics provide unprecedented opportunities to understand how biological processes work in subcellularand multicellular systems. The interdisciplinary research field of Video Bioinformatics is defined by BirBhanu as the automated processing, analysis, understanding, data mining, visualization, query-basedretrieval/storage of biological spatiotemporal events/data and knowledge extracted from dynamic imagesand microscopic videos. Video bioinformatics attempts to provide a deeper understanding of continuousand dynamic life processes.Genome sequences alone lack spatial and temporal information, and video imaging of specific moleculesand their spatiotemporal interactions, using a range of imaging methods, are essential to understandhow genomes create cells, how cells constitute organisms, and how errant cells cause disease. The bookexamines interdisciplinary research issues and challenges with examples that deal with organismal dynamics,intercellular and tissue dynamics, intracellular dynamics, protein movement, cell signaling and softwareand databases for video bioinformatics.Topics and Features• Covers a set of biological problems, their significance, live-imaging experiments, theory andcomputational methods, quantifiable experimental results and discussion of results.• Provides automated methods for analyzing mild traumatic brain injury over time, identifying injurydynamics after neonatal hypoxia-ischemia and visualizing cortical tissue changes during seizureactivity as examples of organismal dynamics• Describes techniques for quantifying the dynamics of human embryonic stem cells with examplesof cell detection/segmentation, spreading and other dynamic behaviors which are important forcharacterizing stem cell health• Examines and quantifies dynamic processes in plant and fungal systems such as cell trafficking,growth of pollen tubes in model systems such as Neurospora Crassa and Arabidopsis• Discusses the dynamics of intracellular molecules for DNA repair and the regulation of cofilintransport using video analysis• Discusses software, system and database aspects of video bioinformatics by providing examples of5D cell tracking by FARSIGHT open source toolkit, a survey on available databases and software,biological processes for non-verbal communications and identification and retrieval of moth imagesThis unique text will be of great interest to researchers and graduate students of Electrical Engineering,Computer Science, Bioengineering, Cell Biology, Toxicology, Genetics, Genomics, Bioinformatics, ComputerVision and Pattern Recognition, Medical Image Analysis, and Cell Molecular and Developmental Biology.The large number of example applications will also appeal to application scientists and engineers.Dr. Bir Bhanu is Distinguished Professor of Electrical & C omputer Engineering, Interim Chair of theDepartment of Bioengineering, Cooperative Professor of Computer Science & Engineering, and MechanicalEngineering and the Director of the Center for Research in Intelligent Systems, at the University of California,Riverside, California, USA.Dr. Prue Talbot is Professor of Cell Biology & Neuroscience and Director of the Stem Cell Center and Core atthe University of California Riverside, California, USA. |
| cell therapy quality control: 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 |
| cell therapy quality control: 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 |
| cell therapy quality control: Phase Appropriate GMP for Biological Processes Trevor Deeks, 2018-04 |
| cell therapy quality control: Human Genome Editing National Academies of Sciences, Engineering, and Medicine, National Academy of Medicine, National Academy of Sciences, Committee on Human Gene Editing: Scientific, Medical, and Ethical Considerations, 2017-08-13 Genome editing is a powerful new tool for making precise alterations to an organism's genetic material. Recent scientific advances have made genome editing more efficient, precise, and flexible than ever before. These advances have spurred an explosion of interest from around the globe in the possible ways in which genome editing can improve human health. The speed at which these technologies are being developed and applied has led many policymakers and stakeholders to express concern about whether appropriate systems are in place to govern these technologies and how and when the public should be engaged in these decisions. Human Genome Editing considers important questions about the human application of genome editing including: balancing potential benefits with unintended risks, governing the use of genome editing, incorporating societal values into clinical applications and policy decisions, and respecting the inevitable differences across nations and cultures that will shape how and whether to use these new technologies. This report proposes criteria for heritable germline editing, provides conclusions on the crucial need for public education and engagement, and presents 7 general principles for the governance of human genome editing. |
| cell therapy quality control: Chimeric Antigen Receptor T Cells Kamilla Swiech, Kelen Cristina Ribeiro Malmegrim, Virgínia Picanço-Castro, 2020-11-24 This volume provides comprehensive methods from expert scientists working in the Chimeric Antigen Receptor T Cell (CAR-T Cell) field. Chapters guide readers through the state-of-art of CAR-T cell technology, CAR design and vector production, CAR-T cell generation and manufacturing, CAR-T cell characterization, and quality control. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, Chimeric Antigen Receptor T Cells: Development and Production aims to be useful in the production of CAR-T cells, especially for therapeutic purposes. |
| cell therapy quality control: Stem Cell Bioengineering Biju Parekkadan, Martin L. Yarmush, 2009 In stem cell research there are several key methods that, once mastered, can be extremely powerful. These methods enable you to rigorously test hypotheses, compare results to gold standards, and may even spur improvements to existing protocols. This book describes numerous methods to derive, manipulate, target, and prepare stem cells for clinical use. The methods described here help you derive and test human embryonic stem cells, analyze bone marrow stem cell function in vitro and in vivo, image a stem cell transplant, cryopreserve stem cells and differentiate stem cells using microscale tec. |
| cell therapy quality control: Development and Manufacture of Protein Pharmaceuticals Steve L. Nail, Michael J. Akers, 2012-12-06 In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality. |
| cell therapy quality control: Chimeric Antigen Receptor T-Cell Therapies for Cancer E-Book Daniel W. Lee, Nirali N. Shah, 2019-11-30 From patient referral to post-therapy management, Chimeric Antigen Receptor (CAR) T-Cell Therapies for Cancer: A Practical Guide presents a comprehensive view of CAR modified T-cells in a concise and practical format. Providing authoritative guidance on the implementation and management of CAR T-cell therapy from Drs. Daniel W. Lee and Nirali N. Shah, this clinical resource keeps you up to date on the latest developments in this rapidly evolving area. - Covers all clinical aspects, including patient referral, toxicities management, comorbidities, bridging therapy, post-CAR monitoring, and multidisciplinary approaches to supportive care. - Includes key topics on associated toxicities such as predictive biomarkers, infections, and multidisciplinary approaches to supportive care. - Presents current knowledge on FDA approved CAR T-cell products as well as developments on the horizon. - Editors and authors represent leading investigators in academia and worldwide pioneers of CAR therapy. |
| cell therapy quality control: 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- |
| cell therapy quality control: 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. |
| cell therapy quality control: FDA Biotechnology Inspection Guide United States. Food and Drug Administration, 1991 |
| cell therapy quality control: Usp38-Nf33 United States Pharmacopeial Convention, 2014-11-01 |
| cell therapy quality control: Cell Line Development Mohamed Al-Rubeai, 2009-08-11 Mammalian cell lines command an effective monopoly for the production of therapeutic proteins that require post-translational modifications. This unique advantage outweighs the costs associated with mammalian cell culture, which are far grater in terms of development time and manufacturing when compared to microbial culture. The development of cell lines has undergone several advances over the years, essentially to meet the requirement to cut the time and costs associated with using such a complex hosts as production platforms. This book provides a comprehensive guide to the methodology involved in the development of cell lines and the cell engineering approach that can be employed to enhance productivity, improve cell function, glycosylation and secretion and control apoptosis. It presents an overall picture of the current topics central to expression engineering including such topics as epigenetics and the use of technologies to overcome positional dependent inactivation, the use of promoter and enhancer sequences for expression of various transgenes, site directed engineering of defined chromosomal sites, and examination of the role of eukaryotic nucleus as the controller of expression of genes that are introduced for production of a desired product. It includes a review of selection methods for high producers and an application developed by a major biopharmaceutical industry to expedite the cell line development process. The potential of cell engineering approch to enhance cell lines through the manipulation of single genes that play important roles in key metabolic and regulatory pathways is also explored throughout. |
| cell therapy quality control: 3D Bioprinting Jeremy M. Crook, 2020-03-24 This volume explores the latest developments and contributions to the field of 3D bioprinting, and discusses its use for quality R&D and translation. The chapters in this book are divided into two parts: Part one covers generic themes in bioprinting to introduce novice readers to the field, while also providing experts with new and helpful information. Part two discusses protocols used to prepare, characterize, and print a variety of biomaterials, cells, and tissues. These chapters also emphasize methods used for printing defined and humanized constructs suitable for human tissue modelling in research and applicable to clinical product development. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Cutting-edge and comprehensive, 3D Bioprinting: Methods and Protocols is a valuable resource for researchers and bioprinting laboratories/facilities interested in learning more about this rapidly evolving technology. |
| cell therapy quality control: The Promise of Adolescence National Academies of Sciences, Engineering, and Medicine, Health and Medicine Division, Division of Behavioral and Social Sciences and Education, Board on Children, Youth, and Families, Committee on the Neurobiological and Socio-behavioral Science of Adolescent Development and Its Applications, 2019-07-26 Adolescenceâ€beginning with the onset of puberty and ending in the mid-20sâ€is a critical period of development during which key areas of the brain mature and develop. These changes in brain structure, function, and connectivity mark adolescence as a period of opportunity to discover new vistas, to form relationships with peers and adults, and to explore one's developing identity. It is also a period of resilience that can ameliorate childhood setbacks and set the stage for a thriving trajectory over the life course. Because adolescents comprise nearly one-fourth of the entire U.S. population, the nation needs policies and practices that will better leverage these developmental opportunities to harness the promise of adolescenceâ€rather than focusing myopically on containing its risks. This report examines the neurobiological and socio-behavioral science of adolescent development and outlines how this knowledge can be applied, both to promote adolescent well-being, resilience, and development, and to rectify structural barriers and inequalities in opportunity, enabling all adolescents to flourish. |
| cell therapy quality control: 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. |
| cell therapy quality control: Clinical Data Management Richard K. Rondel, Sheila A. Varley, Colin F. Webb, 2000-02-03 Extensively revised and updated, with the addition of new chapters and authors, this long-awaited second edition covers all aspects of clinical data management. Giving details of the efficient clinical data management procedures required to satisfy both corporate objectives and quality audits by regulatory authorities, this text is timely and an important contribution to the literature. The volume: * is written by well-known and experienced authors in this area * provides new approaches to major topics in clinical data management * contains new chapters on systems software validation, database design and performance measures. It will be invaluable to anyone in the field within the pharmaceutical industry, and to all biomedical professionals working in clinical research. |
| cell therapy quality control: Guide to Cell Therapy GxP Joaquim Vives, Gloria Carmona, 2015-07-24 Guide to Cell Therapy GxP is a practical guide to the implementation of quality assurance systems for the successful performance of all cell-based clinical trials. The book covers all information that needs to be included in investigational medicinal product dossier (IMPD), the launching point for any clinical investigation, and beyond. Guide to Cell Therapy GxP bridges a knowledge gap with the inclusion of examples of design of GLP-compliant preclinical studies; design of bioprocesses for autologous/allogeneic therapies; and instruction on how to implement GLP/GMP standards in centers accredited with other quality assurance standards. Guide to Cell Therapy GxP is an essential resource for scientists and researchers in hospitals, transfusion centers, tissue banks, and other research institutes who may not be familiar with the good scientific practice regulations that were originally designed for product development in corporate environments. This book is also a thorough resource for PhD students, Post-docs, Principal Investigators, Quality Assurance Units, and Government Inspectors who want to learn more about how quality standards are implemented in public institutions developing cell-based products. - Easy access to important information on current regulations, state-of-the-art techniques, and recent advances otherwise scattered on various funding websites, within conference proceedings, or maintained in local knowledge - Features protocols, techniques for trouble-shooting common problems, and an explanation of the advantages and limitations of a technique in generating conclusive data - Includes practical examples of successful implementation of quality standards |
| cell therapy quality control: Human Pluripotent Stem Cells Philip H. Schwartz, Robin L. Wesselschmidt, 2011-08-09 Almost daily, new technologies are being presented that move the field of human pluripotent stem cell research towards a future that may yield highly-effective, personalized medical treatments. Three enabling technologies at hand for human PSCs are 1) directed reprogramming of somatic cells, which eliminate many of the ethical issues associated with the derivation and use of human PSCs, increase genetic diversity of the available human PSC lines, and give rise to better in vitro human disease models; 2) the discovery that a Rho-associated protein Kinase (ROCK) inhibitor allows for efficient single cell passaging and cryopreservation, increasing the efficiency and reliability of hPSC culture; and 3) defined, animal-component-free media, which lay the groundwork for simplified scale-up for therapeutic applications, differentiation protocols, and toxicology screens. The aforementioned technologies can be found in Human Pluripotent Stem Cells: Methods and Protocols, a compilation of 33 detailed protocols in six categories of PSC research that cover laboratory essentials and the derivation of new PSC lines, including induced PSC lines, as well as their growth, maintenance, characterization, genetic manipulation, and differentiation. Written in the successful Methods in Molecular BiologyTM series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and accessible, Human Pluripotent Stem Cells: Methods and Protocols serves as an ideal guide to scientists conducting their own pluripotent cell research programs and makes great strides towards furthering human knowledge and, ultimately, improving the human condition. |
| cell therapy quality control: Cell Therapy Adrian P. Gee, 2021-11-10 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. |
| cell therapy quality control: Genetic Engineering of Mesenchymal Stem Cells Jan A. Nolta, 2006-02-09 Bone marrow derived mesenchymal stem cells (MSC) have the potential to form bone, cartilage, tendon, fibroblast, fat, and muscle, and may have other very exciting potentials such as contributing to the repair of damaged heart and skeletal muscle, liver, pancreas, kidney, spinal cord, and even brain. MSC have been reported to initiate revascularization after injury, to facilitate engraftment of blood-forming stem cells, and to reduce the incidence of graft-vs. host disease through their immune-suppressive qualities. Finally, bone marrow-derived MSC have been reported to home to areas of solid tumor revascularization, and thus may be used as delivery vehicles to target ablative agents into dividing tumor cells. Recently the characteristics of human MSC from adipose (fat) tissue have also been identified. The possibility of repairing tissues, speeding stem cell engraftment, and targeting solid tumors for specific killing, using MSC easily harvested from bone marrow, or better yet, from unwanted fat tissue, holds broad appeal, and is an intriguing possibility that could have dramatic effect on health care. This book has information on how to isolate, grow, and characterize MSC from marrow and fat, and gives important insight into how these cells may be used for gene delivery and cellular therapies in the future. Updates on emerging clinical trials are given. |
| cell therapy quality control: The EBMT Handbook Nicolaus Kröger, Mohamad Mohty, Carlo Dufour, 2020-10-08 This Open Access edition of the European Society for Blood and Marrow Transplantation (EBMT) handbook addresses the latest developments and innovations in hematopoietic stem cell transplantation and cellular therapy. Consisting of 93 chapters, it has been written by 175 leading experts in the field. Discussing all types of stem cell and bone marrow transplantation, including haplo-identical stem cell and cord blood transplantation, it also covers the indications for transplantation, the management of early and late complications as well as the new and rapidly evolving field of cellular therapies. This book provides an unparalleled description of current practices to enhance readers' knowledge and practice skills. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors. |
Advanced Topics: Successful Development of Quality Cell and …
• Expect control to increase as process development and clinical study progress • Process control overlaps with product quality attribute characterization.
Cell Therapy Manufacturing and Quality Control: Current …
In this review, we describe the current knowledge and experience of developing large-scale production of BM MSCs, challenges and controls for GMP compliances and safety. Citation: …
Points to Consider on the Manufacture and Quality control of …
Somatic cell therapy involves a defined procedure of administering modified autologous or allogeneic cells for achieving specific cellular functions in specific tissues or organs of the …
CMC Challenges for Accelerated Development of Human Cell …
A Critical Quality Attribute (CQA) is a physical, chemical, biological, or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the …
Quality Controls in Cellular Immunotherapies: Rapid ... - Cell …
Cell-based immunotherapies are among the most prom-ising approaches for developing effective and targeted immune response. However, their clinical usefulness and the evaluation of their …
Quality cell therapy manufacturing by design - Nature
Nov 25, 2014 · Here we review key QbD concepts (Box 1) and discuss their appli-cation to four investigational CTPs: pluripotent stem cell (PSC)-derived cardiomyocytes, hematopoietic stem …
GUIDE FOR MANUFACTURE AND QUALITY CONTROL OF …
GUIDE FOR MANUFACTURE AND QUALITY CONTROL OF ADVANCED CELL THERAPY PRODUCTS 1. INTRODUCTION In veterinary medicine, the number of commercial …
CELL THERAPY QUALITY CONTROL WITHOUT COMPLEXITY
SOME CHALLENGES IN CELL THERAPY QC INCLUDE: • Complex sample and reagent preparation • Limited numbers of highly skilled technicians • Costly maintenance • Highly …
Cell Therapy Manufacturing and Quality Control: Current …
GMP compliance processing such as cell culture, expansion and cryopreservation is mandatory for making the cell therapy effective. MSCs from various tissue sources should be cultured for...
Cellular Therapy Products - U.S. Food and Drug Administration
In terms of quality control, there are a number of stages in the manufacturing process where you can exercise process control in order to ensure product quality.
CELL MANUFACTURING ROADMAP TO 2030
Process Monitoring and Quality Control — More consistent, reliable, and lower-cost cell manufacturing processes—through the use of sophisticated process simulation and modeling, …
Guideline on quality, non-clinical and clinical requirements for ...
(EMA/CAT/600280/2010 rev.1), form the basis for the classification as somatic cell therapy, tissue engineered product or gene therapy. For the purposes of this guideline, the main scientific
Considerations in Validating Car T Cell Therapy MFG …
• Cell therapy process development and process control considerations ─ Every batch is unique ─ requires a robust and/or flexible control strategy to ensure product/process consistency
Cell therapy: cGMP facilities and manufacturing - mltj.online
quality assurance programs, which established a Quality System approach to control collection, processing, stor-age and release of cell therapy products and also address the following …
The top four challenges and solutions Navigating cell therapy …
Understand the risks and benefits associated with cell therapy workflows. Navigating the cell therapy manufacturing landscape can be a complex journey, especially when open and manual …
Considerations for the development of iPSC-derived cell …
It discusses differences in global guidelines and regulatory frameworks, outlines a series of quality control tests required to ensure the safety of the cell therapy, and provides details and …
Table 3: Cell and Gene Products - Control Strategy - CASSS
While the principles of control strategy for cell and gene therapy products are the same as other parenteral biotherapeutic, there are unique challenges with these newer modalities. Control of …
Concise Review: Process Development Considerations for Cell …
Process devel-opment aims to gain efficiency and drive down costs while maintaining or improving quality. It applies to all process elements such as cell isola-tion, cell characterization, …
Cell-based Therapy ATMPs - European Medicines Agency
to the specific nature of advanced therapy medicinal products, a risk-based approach can be applied to determine the extent of Quality, Nonclinical and Clinical data (including RMP and …
Cell: Cell - Cell Press
Cell publishes findings of unusual significance in any area of experimental biology, including but not limited to cell biology, molecular biology, neuroscience, immunology, virology and …
Cell (biology) - Wikipedia
The cell is the basic structural and functional unit of all forms of life. Every cell consists of cytoplasm enclosed within a membrane; many cells contain organelles, each with a specific …
Cell | Definition, Types, Functions, Diagram, Division, Theory,
Apr 25, 2025 · cell, in biology, the basic membrane-bound unit that contains the fundamental molecules of life and of which all living things are composed. A single cell is often a complete …
The cell: Types, functions, and organelles - Medical News Today
Dec 19, 2023 · A cell is the smallest living organism and the basic unit of life on earth. Together, trillions of cells make up the human body. Cells have three parts: the membrane, the nucleus, …
Cell – Definition, Structure, Types, Functions, Examples
Apr 7, 2024 · A cell is the basic structural and functional unit of all living organisms, responsible for various life processes and containing essential biological
What Is a Cell? | Learn Science at Scitable - Nature
All cells evolved from a common ancestor and use the same kinds of carbon-based molecules. Learn how cell function depends on a diverse group of nucleic acids, proteins, lipids, and sugars.
What is a cell? - MedlinePlus
Feb 22, 2021 · Cells are the basic building blocks of all living things. The human body is composed of trillions of cells. They provide structure for the body, take in nutrients from food, …
Cell Definition - BYJU'S
Jan 14, 2018 · Cells are the structural, functional, and biological units of all living beings. A cell can replicate itself independently. Hence, they are known as the building blocks of life. Each …
Introduction to cells - Basic Biology
Aug 30, 2020 · A cell is the simplest unit of life and they are responsible for keeping an organism alive and functioning. This introduction to cells is the starting point for the area of biology that …
Overview of Cells - Visible Body
What are cells and what do they do? The nucleus of a eukaryotic cell contains its DNA. Cells are the microscopic units that make up humans and every other living organism. Some organisms …
