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| cell therapy cgmp facilities and 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. |
| cell therapy cgmp facilities and manufacturing: 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 cgmp facilities and 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 |
| cell therapy cgmp facilities and 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. |
| cell therapy cgmp facilities and manufacturing: A Handbook of Gene and Cell Therapy Clévio Nóbrega, Liliana Mendonça, Carlos A. Matos, 2020-06-27 This is a reference handbook for young researchers exploring gene and cell therapy. Gene therapy could be defined as a set of strategies modifying gene expression or correcting mutant/defective genes through the administration of DNA (or RNA) to cells, in order to treat disease. Important advances like the discovery of RNA interference, the completion of the Human Genome project or the development of induced pluripotent stem cells (iPSc) and the basics of gene therapy are covered. This is a great book for students, teachers, biomedical researchers delving into gene/cell therapy or researchers borrowing skills from this scientific field. |
| cell therapy cgmp facilities and 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. |
| cell therapy cgmp facilities and manufacturing: 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 cgmp facilities and manufacturing: Phase Appropriate GMP for Biological Processes Trevor Deeks, 2018-04 |
| cell therapy cgmp facilities and manufacturing: Biomaterials and Regenerative Medicine Peter X. Ma, 2014-07-24 Written by world-leading experts, this book focusses on the role of biomaterials in stem cell research and regenerative medicine. Emphasising basic principles and methodology, it covers stem cell interactions, fabrication technologies, design principles, physical characterisation and biological evaluation, across a broad variety of systems and biomaterials. Topics include: stem cell biology, including embryonic stem cells, IPS, HSC and progenitor cells; modern scaffold structures, including biopolymer, bioceramic, micro- and nanofiber, ECM and biohydrogel; advanced fabrication technologies, including computer-aided tissue engineering and organ printing; cutting-edge drug delivery systems and gene therapy techniques; and medical applications spanning hard and soft tissues, the cardiovascular system and organ regeneration. With a contribution by Nobel laureate Shinya Yamanaka, this is a must-have reference for anyone in the field of biomaterials, stem cell biology and engineering, tissue engineering and regenerative medicine. |
| cell therapy cgmp facilities and 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. |
| cell therapy cgmp facilities and manufacturing: Biopharmaceutical Processing Gunter Jagschies, Eva Lindskog, Karol Lacki, Parrish M. Galliher, 2018-01-18 Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. - Offers a comprehensive, go-to reference for daily work decisions - Covers both upstream and downstream processes - Includes case studies that emphasize financial outcomes - Presents summaries, decision grids, graphs and overviews for quick reference |
| cell therapy cgmp facilities and 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. |
| cell therapy cgmp facilities and manufacturing: Continuous Manufacturing for the Modernization of Pharmaceutical Production National Academies of Sciences, Engineering, and Medicine, Division on Earth and Life Studies, Board on Chemical Sciences and Technology, 2019-04-05 On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop. |
| cell therapy cgmp facilities and manufacturing: Flow Cytometry Alice Longobardi Givan, 2013-04-10 Flow cytometry continually amazes scientists with its ever-expanding utility. Advances in flow cytometry have opened new directions in theoretical science, clinical diagnosis, and medical practice. The new edition of Flow Cytometry: First Principles provides a thorough update of this now classic text, reflecting innovations in the field while outlining the fundamental elements of instrumentation, sample preparation, and data analysis. Flow Cytometry: First Principles, Second Edition explains the basic principles of flow cytometry, surveying its primary scientific and clinical applications and highlighting state-of-the-art techniques at the frontiers of research. This edition contains extensive revisions of all chapters, including new discussions on fluorochrome and laser options for multicolor analysis, an additionalsection on apoptosis in the chapter on DNA, and new chapters onintracellular protein staining and cell sorting, including high-speed sorting and alternative sorting methods, as well as traditional technology. This essential resource: Assumes no prior knowledge of flow cytometry Progresses with an informal, engaging lecture style from simpleto more complex concepts Offers a clear introduction to new vocabulary, principles of instrumentation, and strategies for data analysis Emphasizes the theory relevant to all flow cytometry, with examples from a variety of clinical and scientific fields Flow Cytometry: First Principles, Second Edition provides scientists, clinicians, technologists, and students with the knowledge necessary for beginning the practice of flow cytometry and for understanding related literature. |
| cell therapy cgmp facilities and manufacturing: A Guide to Human Gene Therapy Roland W. Herzog, Sergei Zolotukhin, 2010 1. Non-viral gene therapy / Sean M. Sullivan -- 2. Adenoviral vectors / Stuart A. Nicklin and Andrew H. Baker -- 3. Retroviral vectors and integration analysis / Cynthia C. Bartholomae [und weitere] -- 4. Lentiviral vectors / Janka Matrai, Marinee K.L. Chuah and Thierry VandenDriessche -- 5. Herpes simplex virus vectors / William F. Goins [und weitere] -- 6. Adeno-Associated Viral (AAV) vectors / Nicholas Muzyczka -- 7. Regulatory RNA in gene therapy / Alfred. S. Lewin -- 8. DNA integrating vectors (Transposon, Integrase) / Lauren E. Woodard and Michele P. Calos -- 9. Homologous recombination and targeted gene modification for gene therapy / Matthew Porteus -- 10. Gene switches for pre-clinical studies in gene therapy / Caroline Le Guiner [und weitere] -- 11. Gene therapy for central nervous system disorders / Deborah Young and Patricia A. Lawlor -- 12. Gene therapy of hemoglobinopathies / Angela E. Rivers and Arun Srivastava -- 13. Gene therapy for primary immunodeficiencies / Aisha Sauer, Barbara Cassani and Alessandro Aiuti -- 14. Gene therapy for hemophilia / David Markusic, Babak Moghimi and Roland Herzog -- 15. Gene therapy for obesity and diabetes / Sergei Zolotukhin and Clive H. Wasserfall -- 16. Gene therapy for Duchenne muscular dystrophy / Takashi Okada and Shin'ichi Takeda -- 17. Cancer gene therapy / Kirsten A.K. Weigel-Van Aken -- 18. Gene therapy for autoimmune disorders / Daniel F. Gaddy, Melanie A. Ruffner and Paul D. Robbins -- 19. Gene therapy for inherited metabolic storage diseases / Cathryn Mah -- 20. Retinal diseases / Shannon E. Boye, Sanford L. Boye and William W. Hauswirth -- 21. A brief guide to gene therapy treatments for pulmonary diseases / Ashley T. Martino, Christian Mueller and Terence R. Flotte -- 22. Cardiovascular disease / Darin J. Falk, Cathryn S. Mah and Barry J. Byrne |
| cell therapy cgmp facilities and manufacturing: Cardiac Regeneration Masaki Ieda, Wolfram-Hubertus Zimmermann, 2017-10-27 This Volume of the series Cardiac and Vascular Biology offers a comprehensive and exciting, state-of-the-art work on the current options and potentials of cardiac regeneration and repair. Several techniques and approaches have been developed for heart failure repair: direct injection of cells, programming of scar tissue into functional myocardium, and tissue-engineered heart muscle support. The book introduces the rationale for these different approaches in cell-based heart regeneration and discusses the most important considerations for clinical translation. Expert authors discuss when, why, and how heart muscle can be salvaged. The book represents a valuable resource for stem cell researchers, cardiologists, bioengineers, and biomedical scientists studying cardiac function and regeneration. |
| cell therapy cgmp facilities and manufacturing: Biopharmaceuticals Basanta Kumara Behera, 2020-12-07 Biopharmaceuticals: Challenges and Opportunities This book highlights how the traditional microbial process technology has been upgraded for the production of biologic drugs how manufacturing processes have evolved to meet the global market demand with quality products under the guidelines of internally recognized regulatory bodies. It also carries information on how, armed with a deeper understanding of life-threatening diseases, biopharmaceutical companies and the life sciences industry have developed formal and informal partnerships with researchers in institutes, universities, and other R&D organizations to fulfil timely, quality production with perfect safety and security. One of the most interesting aspects of this book is the conceptual development of personalized medicine (or precision medicine) to provide the right treatment to the right patient, at the right dose at an earlier stage of development, for genetic diseases. Besides this, it also highlights the most challenging aspects of modern biopharmaceutical science, focusing on the hot topics such as design and development of biologic drugs; the use of diversified groups of host cells belonging to animals, plants, microbes, insects, and mammals; stem cell therapy and gene therapy; supply chain management of biopharmaceuticals; and the future scope of biopharmaceutical industry development. This book is the latest resource for a wide circle of scientists, students, and researchers involved in understanding and implementing the knowledge of biopharmaceuticals to develop life-saving biologic drugs and to bring awareness to the development of personalized treatment that can potentially offer patients a faster diagnosis, fewer side effects, and better outcomes. Features: Explains how the traditional cell culture methodology has been changed to a fully continuous or partially continuous process Explains how to design and fabricate living organs of body by 3D bioprinting technology Focuses on how a biopharmaceutical company deals with various problems of regulatory bodies and develops innovative biologic drugs Narrates in detail the updated information on stem cell therapy and gene therapy Explains the development strategies and clinical significance of biosimilars and biobetters Highlights the supply chain management of biopharmaceuticals |
| cell therapy cgmp facilities and 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 |
| cell therapy cgmp facilities and manufacturing: New Bioprocessing Strategies: Development and Manufacturing of Recombinant Antibodies and Proteins Bob Kiss, Uwe Gottschalk, Michael Pohlscheidt, 2018-12-06 This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English. |
| cell therapy cgmp facilities and 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 |
| cell therapy cgmp facilities and manufacturing: Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Ganapathy Subramanian, 2021-12-20 Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Explore new trends in continuous biomanufacturing with contributions from leading practitioners in the field With the increasingly widespread acceptance and investment in the ??technology, the last decade has demonstrated the utility of continuous ??processing in the pharmaceutical industry. In Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing, distinguished biotechnologist Dr. Ganapathy Subramanian delivers a comprehensive exploration of the potential of the continuous processing of biological products and discussions of future directions in advancing continuous processing to meet new challenges and demands in the manufacture of therapeutic products. A stand-alone follow-up to the editor’s Continuous Biomanufacturing: Innovative Technologies and Methods published in 2017, this new edited volume focuses on critical aspects of process intensification, process control, and the digital transformation of biopharmaceutical processes. In addition to topics like the use of multivariant data analysis, regulatory concerns, and automation processes, the book also includes: Thorough introductions to capacitance sensors to control feeding strategies and the continuous production of viral vaccines Comprehensive explorations of strategies for the continuous upstream processing of induced microbial systems Practical discussions of preparative hydrophobic interaction chromatography and the design of modern protein-A-resins for continuous biomanufacturing In-depth examinations of bioprocess intensification approaches and the benefits of single use for process intensification Perfect for biotechnologists, bioengineers, pharmaceutical engineers, and process engineers, Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing is also an indispensable resource for chemical engineers seeking a one-stop reference on continuous biomanufacturing. |
| cell therapy cgmp facilities and manufacturing: Bacteriophages David R. Harper, Stephen T. Abedon, Benjamin H. Burrowes, Malcolm L. McConville, 2021-01-30 This first major reference work dedicated to the mannifold industrial and medical applications of bacteriophages provides both theoretical and practical insights into the emerging field of bacteriophage biotechnology. The book introduces to bacteriophage biology, ecology and history and reviews the latest technologies and tools in bacteriophage detection, strain optimization and nanotechnology. Usage of bacteriophages in food safety, agriculture, and different therapeutic areas is discussed in detail. This book serves as essential guide for researchers in applied microbiology, biotechnology and medicine coming from both academia and industry. |
| cell therapy cgmp facilities and manufacturing: Regenerative Medicine and Stem Cell Biology Nagwa El-Badri, 2020-11-27 This textbook covers the basic aspects of stem cell research and applications in regenerative medicine. Each chapter includes a didactic component and a practical section. The book offers readers insights into: How to identify the basic concepts of stem cell biology and the molecular regulation of pluripotency and stem cell development. How to produce induced pluripotent stem cells (iPSCs) and the basics of transfection. The biology of adult stem cells, with particular emphasis on mesenchymal stromal cells and hematopoietic stem cells, and the basic mechanisms that regulate them. How cancer stem cells arise and metastasize, and their properties. How to develop the skills needed to isolate, differentiate and characterize adult stem The clinical significance of stem cell research and the potential problems that need to be overcome. Evaluating the use of stem cells for tissue engineering and therapies (the amniotic membrane) The applications of bio-nanotechnology in stem cell research. How epigenetic mechanisms, including various DNA modifications and histone dynamics, are involved in regulating the potentiality and differentiation of stem cells. The scientific methods, ethical considerations and implications of stem cell research. |
| cell therapy cgmp facilities and manufacturing: Targeted Radionuclide Therapy Tod W. Speer, 2012-03-28 Radioimmunotherapy, also known as systemic targeted radiation therapy, uses antibodies, antibody fragments, or compounds as carriers to guide radiation to the targets. It is a topic rapidly increasing in importance and success in treatment of cancer patients. This book represents a comprehensive amalgamation of the radiation physics, chemistry, radiobiology, tumor models, and clinical data for targeted radionuclide therapy. It outlines the current challenges and provides a glimpse at future directions. With significant advances in cell biology and molecular engineering, many targeting constructs are now available that will safely deliver these highly cytotoxic radionuclides in a targeted fashion. A companion website includes the full text and an image bank. |
| cell therapy cgmp facilities and manufacturing: Advances in Application of Stem Cells: From Bench to Clinics Firdos Alam Khan, 2021-09-14 The field of stem cell biology is expanding with a continued surge of new information related to its applications. Over past few years, stem cells have been extensively used in cell therapy, tissue engineering, in vitro drug testing among others. At the moment there is no single book available which comprehensively describes the significance of various application of stem cells derived from embryonic and adult sources from lab to clinics. In this edited volume, we discuss basics and advanced topics of stem cells to help researchers, students and professional find the most important information in a single source of updated information about stem cells and relevant applications. This book is divided in 12 chapters and covers topics such as in vitro cell culture, 3D cell culture, cell therapy, tissue engineering, cell factory, cell functionality, in vitro drug testing, organ development, autologous transplantation, allogeneic transplantation, adult stem cells, multipotent stem cells, induced pluripotent stem cells, a pluripotent and embryonic stem cells. |
| cell therapy cgmp facilities and 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. |
| cell therapy cgmp facilities and manufacturing: Pharmaceutical Manufacturing Handbook Shayne Cox Gad, 2008-03-11 This handbook features contributions from a team of expert authors representing the many disciplines within science, engineering, and technology that are involved in pharmaceutical manufacturing. They provide the information and tools you need to design, implement, operate, and troubleshoot a pharmaceutical manufacturing system. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. |
| cell therapy cgmp facilities and manufacturing: Rare Diseases and Orphan Products Institute of Medicine, Board on Health Sciences Policy, Committee on Accelerating Rare Diseases Research and Orphan Product Development, 2011-04-03 Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development. |
| cell therapy cgmp facilities and manufacturing: Pharmaceutical Manufacturing Handbook Shayne Cox Gad, 2008-04-04 With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing. |
| cell therapy cgmp facilities and manufacturing: Preservation of Cells Allison Hubel, 2018-02-13 Helps those that use cell preservation to develop new protocols or improve existing protocols This book provides readers with the tools needed to develop or debug a preservation protocol for cells. The core structure and content of the text grew from a professional short course that has been offered at the Biopreservation Core Resource for the last 10 years. This comprehensive text describes, step by step, the individual elements of a protocol, including the relevant scientific principles for each phase of the protocol. It can be used by anyone who is involved in cell preservation—even by those who are not experts in freezing of cells—because it provides the scientific basis for those that want to understand the basis for the protocol. Preservation of Cells: A Practical Manual begins by first introducing readers to the subject of preserving cells. It then goes on to cover Pre-freeze Processing and Characterization; Formulation and Introduction of Cryopreservation Solutions; Freezing Protocols; Storage and Shipping of Frozen Cells; Thawing and Post Thaw Processing; Post-thaw Assessment; and Algorithm-driven Protocol Optimization. Clearly explains the reasons behind every step in the development of a preservation protocol and the scientific principles behind them Provides alternative modes of preservation for when conventional methods of cryopreservation are not appropriate for a given cell type or application Enables more organization to achieve improved post thaw recoveries and process consistency Preservation of Cells: A Practical Manual is an important book for researchers, laboratory technicians and students in cell biology, stem cell biology, tissue engineering, and regenerative medicine. It is also useful to cell bankers, regenerative medicine, biomarker discovery or precision medicine companies, and cell therapy labs, blood bankers, biobankers, and biotechnology companies. |
| cell therapy cgmp facilities and manufacturing: 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 cgmp facilities and manufacturing: FDA Investigations Operations Manual Food and Drug Administration, 2003 Available now to FDA-regulated organizations, this manual allows facility managers to look at their operation's regulatory compliance through the eyes of the government. Because this is the primary reference manual used by FDA personnel to conduct field investigation activities, you can feel confident you are preparing appropriate planning or action. This manual includes revised instructions regarding the release of information and covers FDA's policies and expectations on a comprehensive range of topics: FDA's authority to enter and inspect, inspection notification, detailed inspection procedures, recall monitoring, inspecting import procedures, computerized data requests, federal/state inspection relationships, discussions with management regarding privileged information, seizure and prosecution, HACCP, bioengineered food, dietary supplements, cosmetics, bioterrorism, and product disposition. The manual also includes a directory of Office of Regulatory Affairs offices and divisions. |
| cell therapy cgmp facilities and manufacturing: 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 cgmp facilities and manufacturing: Viral Vectors for Gene Therapy Otto-Wilhelm Merten, Mohamed Al-Rubeai, 2011-05-19 The huge potential for gene therapy to cure a wide range of diseases has led to high expectations and a great increase in research efforts in this area, particularly in the study of delivery via viral vectors, widely considered to be more efficient than DNA transfection. In Viral Vectors for Gene Therapy: Methods and Protocols, experts in the field present a collection of their knowledge and experience featuring methodologies that involve virus production, transferring protocols, and evaluating the efficacy of gene products. While thoroughly covering the most popular viral vector systems of adenovirus, retrovirus, and adeno-associated virus, this detailed volume also explores less common viral vector systems such as baculovirus, herpes virus, and measles virus, the growing interest in which is creating a considerable demand for large scale manufacturing and purification procedures. Written in the highly successful Methods in Molecular BiologyTM series format, many chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and vital tips on troubleshooting and avoiding known pitfalls. Comprehensive and practical, Viral Vectors for Gene Therapy: Methods and Protocols provides basic principles accessible to scientists from a wide variety of backgrounds for the development of gene therapy viral products that are safe and effective. |
| cell therapy cgmp facilities and manufacturing: Stem Cell Therapy: A Rising Tide: How Stem Cells Are Disrupting Medicine and Transforming Lives Neil H. Riordan, 2017-06-20 Stem cells are the repair cells of your body. When there aren't enough of them, or they aren't working properly, chronic diseases can manifest and persist. From industry leaders, sport stars, and Hollywood icons to thousands of everyday, ordinary people, stem cell therapy has helped when standard medicine failed. Many of them had lost hope. These are their stories. Neil H Riordan, author of MSC: Clinical Evidence Leading Medicine's Next Frontier, the definitive textbook on clinical stem cell therapy, brings you an easy-to-read book about how and why stem cells work, and why they're the wave of the future. |
| cell therapy cgmp facilities and manufacturing: Islet Transplantation and Beta Cell Replacement Therapy A. M. James Shapiro, James A. M. Shaw, 2007-07-25 Beta cell replacement through transplantation remains the only treatment option for Type 1 diabetes enabling restoration of near-physiological glucose levels without significant hypoglycemia. Outlining the most recent advances and research breakthroughs, this practical guide and reference work explores the impact of islet cell transplantation and brings together leading multidisciplinary proponents critical to future success in the field. Edited by a surgeon and an endocrinologist at the forefront of the technology, this volume considers challenges associated with this procedure including lack of sufficient donor organs and the side effects of immunosuppressive therapy, as well as the potential benefits for current and future patients. Islet Transplantation and Beta Cell Replacement Therapy, after a brief historical overview, examines: the key role of endocrinologists in holistic assessment and selection of islet transplant recipients the factors underlying attrition of islet function over time and need for enhanced graft monitoring post transplantation future in vivo islet imaging setting up new clinical islet transplant programs by outlining potential models and pitfalls-including cost effectiveness and sustainable integrated approaches clinical outcomes and the future direction for islet transplantation, including alternative sources of beta cells, to meet future clinical needs through xenotransplantation, new insulin-producing cells from adult tissue, and stem cell banks |
| cell therapy cgmp facilities and manufacturing: Mesenchymal Stem Cell Assays and Applications Mohan C Vemuri, Lucas G. Chase, Mahendra S. Rao, 2017-05-04 Mesenchymal Stem Cells have seen an unprecedented level of interest in the last decade, primarily due to their relative ease of isolation, the large numbers of cells present in the adult, and the ability to propagate these cells in culture. In Mesenchymal Stem Cell Assays and Applications, expert researchers from across the globe explore the latest techniques to propagate, characterize, and engineer this special cell type. Chapters outline a set of protocols and assays used by leading investigators in the field, providing standards that can be applied by all researchers to the population of cells used in their experiments. Composed in the highly successful Methods in Molecular BiologyTM series format, each chapter contains a brief introduction, step-by-step methods, a list of necessary materials, and a Notes section which shares tips on troubleshooting and avoiding known pitfalls. Ground-breaking and current, Mesenchymal Stem Cell Assays and Applications is a necessary handbook for all researchers working with this ambiguous population of cells. |
| cell therapy cgmp facilities and manufacturing: Building on Canada's Strengths in Regenerative Medicine , 2017-03 |
| cell therapy cgmp facilities and manufacturing: Hematology: Diagnosis and Treatment E-Book Ronald Hoffman, Edward J. Benz, Leslie E. Silberstein, Helen Heslop, Jeffrey Weitz, John Anastasi, 2013-03-29 The Hematology: Diagnosis and Treatment eBook is the ideal mobile resource in hematology! It distills the most essential, practical information from Hematology: Basic Principles and Practice, 6th Edition - the comprehensive masterwork by Drs. Hoffman, Benz, Silberstein, Heslop, Weitz, and Anastasi - into a concise, clinically focused resource that's optimized for reference on any e-reader. Focusing on the dependable, state-of-the-art clinical strategies you need to optimally diagnose and manage the full range of blood diseases and disorders, this eBook is a must-have for every hematologist's mobile device! Apply the latest know-how on heparin-induced thrombocytopenia, stroke, acute coronary syndromes, hematologic manifestations of liver disease, hematologic manifestations of cancer, hematology in aging, and many other hot topics. Get quick, focused answers on the diagnosis and management of blood diseases - in a portable digital format that you can carry and consult anytime, anywhere. View abundant images that mirror the pivotal role hematopathology plays in the practice of modern hematology. Count on all the authority that has made Hematology: Basic Principles and Practice, 6th Edition, edited by Drs. Hoffman, Benz, Silberstein, Heslop, Weitz, and Anastasi, the go-to clinical reference for hematologists worldwide. Consult this title on your favorite e-reader, conduct rapid searches, and adjust font sizes for optimal readability. Compatible with Kindle®, nook®, and other popular devices. |
| cell therapy cgmp facilities and manufacturing: Stem Cell Production Firdos Alam Khan, 2022-03-29 This book examines the technologies and processes for the development and commercial production of stem cells according to cGMP guidelines. The initial chapter of the book discusses the therapeutic potentials of stem cells for the treatment of various diseases, including degenerative disorders and genetic diseases. The book then reviews the recent developments in the cultivation of stem cells in bioreactors, including critical cultural parameters, possible bioreactor configuration and integrations of novel technologies in bioprocess developmental stages. The book also introduces microscopic, molecular, and cellular techniques for characterization of stem cells for regulatory approvals. Further, it describes optimal cell transporting conditions to maintain cell viability and properties. Further, it summarizes characterization strategies of clinical grade stem cells for stem cell therapy. 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. |
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 microbiology, …
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, convert …
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 cell …
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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 consist …
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, …
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 …
Cell | Definition, Types, Functions, Diagram, Division, …
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 …
The cell: Types, functions, and organelles - Medical News To…
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 …
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 …
