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| cold chain logistics in cell therapy: 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. |
| cold chain logistics in cell therapy: Novel Innovation Design for the Future of Health Michael Friebe, 2022-11-26 This book highlights the reasons for an urgently needed revision of the current global healthcare setup, discusses the needed mindset for a future of health, and provides a comprehensive development toolset for disruption (and for the needed incremental innovations towards disruption). Today’s biomedical and health innovation related research in universities encourages activities that lead to incremental innovations with a relatively low risk of failure. The healthcare industry on the other hand provides tools and devices for established healthcare providers to improve the diagnosis and therapy/ treatment of the patients’ health problems. The patient is not in the center of healthcare provision however, and prevention and prediction are not core goals. The current health setup needs to be challenged and disrupted. Disruptions are coming from technologies or processes that lead to a significant (>10x) reduction in cost or price/ performance and that also come with new business models. The need for change, effects of exponential technologies, and the needed shift to prevention and to homecare for health democratization and patient empowerment will be discussed in detail in the first parts of the book. The subsequent sections address several innovation methods with a focus on a novel meta methodology named Purpose Launchpad Health. This is followed by a comprehensive discussion on health entrepreneurship activities and needs. The final section of the book addresses how to train students to become entrepreneurial health innovators, presenting successful curricula and examples of health incubation and accelerator setups. All of the innovation tools presented and used in this book are summarized in the final chapter to help the reader get started planning an entrepreneurial venture. Written by experts from academia and industry, the book covers important basics and best practices, as well as recent developments. Chapters are concise and enriched with key messages, learning objectives and real innovation examples to bridge theory and practice. This book aims to serve as a teaching base for health innovation design and to prepare for health-related entrepreneurial ventures. Readers with medical, biomedical, biotechnology, and health economics backgrounds - and anyone who wants to become a future oriented health innovator or who believes in disruptive approaches - will find this book a useful resource and teaching tool for developing validated products/ services and processes for the future of health. |
| cold chain logistics in cell therapy: Stem Cells in Regenerative Medicine Alain A. Vertes, Nasib Qureshi, Arnold I. Caplan, Lee E. Babiss, 2015-12-02 This book is a unique guide to emerging stem cell technologies and the opportunities for their commercialisation. It provides in-depth analyses of the science, business, legal, and financing fundamentals of stem cell technologies, offering a holistic assessment of this emerging and dynamic segment of the field of regenerative medicine. • Reviews the very latest advances in the technology and business of stem cells used for therapy, research, and diagnostics • Identifies key challenges to the commercialisation of stem cell technology and avenues to overcome problems in the pipeline • Written by an expert team with extensive experience in the business, basic and applied science of stem cell research This comprehensive volume is essential reading for researchers in cell biology, biotechnology, regenerative medicine, and tissue engineering, including scientists and professionals, looking to enter commercial biotechnology fields. |
| cold chain logistics in cell therapy: Biopharmaceutical Manufacturing Ralf Pörtner, 2024-02-11 This volume “Cell Engineerring 11 - Biopharmaceutical Manufacturing: Progress, Trends and Challenges” is a source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation. The book comprises contributions of experts from academia and industry active in the field of cell culture development for the production of recombinant proteins, cell therapy and gene therapy, with consideration of Digital Twin ́s and facility design. The knowledge and expertise of the authors cover disciplines like cell biology, engineering, biotechnology and biomedical sciences. Inevitably, some omissions will occur in the test, but the authors have sought to avoid duplications by extensive cross-referencing to chapters in other volumes of this series and elsewhere. We hope the volume provides a useful compendium of techniques for scientists in industrial and research laboratories active in this field. |
| cold chain logistics in cell therapy: Nanocarrier Vaccines Vivek Chavda, Vasso Apostolopoulos, 2024-04-02 NANOCARRIER VACCINES This book details the benefits, restrictions, and types of nanoparticles used in the creation of vaccines for the treatment and prevention of illnesses. In nanomedicine and nano-delivery systems, materials in the nanoscale range are used as diagnostic instruments or to administer therapeutic compounds to particular targeted regions in a controlled manner. By delivering precise medications to specified locations and targets, nanotechnology provides several advantages in treating chronic human illnesses. The use of nanomedicine (including chemotherapeutic medicines, biological agents, immunotherapeutic agents, etc.) in the treatment of various diseases has recently seen many notable applications. This book aims to be a single source material for understanding all the current and novel advancements in the field of nanotechnology. In this groundbreaking book the reader will find: biodegradable and non-biodegradable formulations and properties such as size, shape, charge, inertness, efficacy, morphology, and more; show how different nanoparticles, such as lipid-based, viral vector-based, and metal, uphold very significant properties individually, suggesting applicability in various management tactics; examines how genetic information-carrying entities are becoming the norm for eradicating some diseases; gathers an exhaustive amount of information on routes of administration such as the oral route, mucosal immunity, intramuscular, subcutaneous, and intradermal; explores the legal regulations for nanotechnology-based approaches. Audience Researchers and pharmacy students in biomedical engineering and chemical engineering, biotechnology, as well as pharmaceutical and biopharmaceutical industry engineers working in drug discovery, chemical biology, computational chemistry, medicinal chemistry, and bioinformatics. |
| cold chain logistics in cell therapy: 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. |
| cold chain logistics in cell therapy: Vaccinology Gregg N. Milligan, Alan D. T. Barrett, 2015-02-16 Vaccinology: An Essential Guide outlines in a clear, practical format the entire vaccine development process, from conceptualization and basic immunological principles through to clinical testing and licensing of vaccines. With an outstanding introduction to the history and practice of vaccinology, it also guides the reader through the basic science relating to host immune responses to pathogens. Covering the safety, regulatory, ethical, and economic and geographical issues that drive vaccine development and trials, it also presents vaccine delivery strategies, novel vaccine platforms (including experimental vaccines and pathogens), antigen development and selection, vaccine modelling, and the development of vaccines against emerging pathogens and agents of bioterror. There are also sections devoted to veterinary vaccines and associated regulatory processes. Vaccinology: An Essential Guide is a perfect tool for designed for undergraduate and graduate microbiologists and immunologists, as well as residents, fellows and trainees of infectious disease and vaccinology. It is also suitable for all those involved in designing and conducting clinical vaccine trials, and is the ideal companion to the larger reference book Vaccinology: Principles and Practice. |
| cold chain logistics in cell therapy: Global Supply Chains in the Pharmaceutical Industry Nozari, Hamed, Szmelter, Agnieszka, 2018-11-09 In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy. |
| cold chain logistics in cell therapy: The Oxford Handbook of Supply Chain Management Thomas Y. Choi, Julie Juan Li, Dale S. Rogers, Tobias Schoenherr, Stephan M. Wagner, This handbook is currently in development, with individual articles publishing online in advance of print publication. At this time, we cannot add information about unpublished articles in this handbook, however the table of contents will continue to grow as additional articles pass through the review process and are added to the site. Please note that the online publication date for this handbook is the date that the first article in the title was published online. |
| cold chain logistics in cell therapy: Venoms and Toxins: At the Crossroads of Basic, Applied and Clinical Immunology Manuela Berto Pucca, Bryan Fry, Wuelton Monteiro, Steve Peigneur, Marco Aurelio Sartim, 2021-08-26 |
| cold chain logistics in cell therapy: Immunisation against infectious diseases David Salisbury, Mary Ramsay, Karen Noakes, 2006-12-11 This is the third edition of this publication which contains the latest information on vaccines and vaccination procedures for all the vaccine preventable infectious diseases that may occur in the UK or in travellers going outside of the UK, particularly those immunisations that comprise the routine immunisation programme for all children from birth to adolescence. It is divided into two sections: the first section covers principles, practices and procedures, including issues of consent, contraindications, storage, distribution and disposal of vaccines, surveillance and monitoring, and the Vaccine Damage Payment Scheme; the second section covers the range of different diseases and vaccines. |
| cold chain logistics in cell therapy: Bioprocessing for Cell-Based Therapies Che J. Connon, 2017-02-06 With contributions from leading, international academics and industrial practitioners, Bioprocessing for Cell-Based Therapies explores the very latest techniques and guidelines in bioprocess production to meet safety, regulatory and ethical requirements, for the production of therapeutic cells, including stem cells. An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout An authoritative, cutting-edge handbook on bioprocessing for the production of therapeutic cells with extensive illustrations in full colour throughout In depth discussion of the application of cell therapy including methods used in the delivery of cells to the patient Includes contributions from experts in both academia and industry, combining a practical approach with cutting edge research The only handbook currently available to provide a state of the art guide to Bioprocessing covering the complete range of cell-based therapies, from experts in academia and industry |
| cold chain logistics in cell therapy: Natural Products Modulate the Sensitivity of Cancer to Anti-PD-1 Based Immunotherapy Qian Ba, Hang Ma, Jean Christopher Chamcheu, Xiaoguang Li, 2023-07-10 |
| cold chain logistics in cell therapy: Immunization in Practice , 2015 This practical guide contains seven modules targeted at district and health facility staff. It intends to meet the demands to improve immunization services so as to reach more infants in a sustainable way, building upon the experiences of polio eradication. It includes materials adapted from polio on planning, monitoring and use of data to improve the service, that can be used at any level. Revising the manual has been a team exercise. There are contributions from a large number of experts, organizations and institutions. This new edition has seven modules. Several new vaccines that have become more readily available and used in recent years have been added. Also the section on integration with other health interventions has been expanded as exciting opportunities and experiences have become evident in the years following the previous edition. Module 1: Target diseases and vaccines Module 2: The vaccine cold chain Module 3: Ensuring safe injections Module 4: Microplanning for reaching every community Module 5: Managing an immunization session Module 6: Monitoring and surveillance Module 7: Partnering with communities. |
| cold chain logistics in cell therapy: The Delivery of Regenerative Medicines and Their Impact on Healthcare Catherine Prescott, Dame Julia Polak, 2016-04-19 Now that prohibitions against stem cell research are relaxing, it is time for the field to move forward with the advances that promise to eliminate so much human suffering. However, it would be naive to ignore the fact that regenerative medicines pose a whole new set of challenges to an industry sector that for decades has geared itself to the deve |
| cold chain logistics in cell therapy: 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 |
| cold chain logistics in cell therapy: Chemical Biology in Regenerative Medicine Charles C. Hong, Ada S. Ao, Jijun Hao, 2014-06-18 Chemical Biology in Regenerative Medicine: Bridging Stem Cells and Future Therapies The field of regenerative medicine has advanced at a rapid pace and this comprehensive summary of new developments is a timely contribution to the field as clinical trials have begun to assess the safety and efficacy of cell-based therapies. In Chemical Biology in Regenerative Medicine, an international team of experts provides an overview of progress towards clinical application in the areas of transplantation (allogenic and autologous), manipulation of niche environment and homing, and cell reprogramming (trans-differentiation and de-differentiation). The book highlights the interdisciplinary approaches undertaken to resolve current technical problems in regenerative medicine, with special attention paid to small molecules and biomaterials engineering. This volume provides an essential overview of this emerging technology for researchers in academic, industrial and clinical environments working in regenerative medicine, chemical biology, biochemistry, cell biology, biomaterials and bioengineering. It is appropriate for training students and newcomers to the field, benefitting readers in broadening their knowledge and giving them insights to regenerative chemical biology, as well as encouraging readers to implement the key points in their own fields of study to develop new technologies. |
| cold chain logistics in cell therapy: Disease Control Priorities, Third Edition (Volume 6) King K. Holmes, Stefano Bertozzi, Barry R. Bloom, Prabhat Jha, 2017-11-06 Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings. |
| cold chain logistics in cell therapy: Supply Chain Management in the Drug Industry Hedley Rees, 2011-04-06 This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage. |
| cold chain logistics in cell therapy: 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. |
| cold chain logistics in cell therapy: Biopharmaceuticals Basanta 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 |
| cold chain logistics in cell therapy: Second Generation Cell and Gene-Based Therapies Alain Vertes, Nathan J. Dowden, Devyn Smith, Nasib Qureshi, 2020-02-07 Second Generation Cell and Gene-Based Therapies: Biological Advances, Clinical Outcomes, and Strategies for Capitalisation serves as the only volume to the market to bridge basic science, clinical therapy, technology development, and business in the field of cellular therapy/cytotherapy. After more than two decades of painstaking fundamental research, the concept of therapeutic cells (stem cells, genes, etc.), beyond the concept of vaccines, is reaching clinical trial, with mounting confidence in the safety and efficacy of these products. Nonetheless, numerous incremental technical advances remain to be achieved. Thus, this volume highlights the possible R&D paths, which will ultimately facilitate clinical delivery of cutting edge curative products.The next waves of innovation are reviewed in depth for hematopoietic stem cells, mesenchymal stem cells, tissue engineering, CAR-T cells, and cells of the immune system, as well as for enabling technologies such as gene and genome editing. Additionally, deep dives in product fundamentals, history of science, pathobiology of diseases, scientific and technological bases, and financing and technology adoption constraints are taken to unravel what will shape the cytotherapy industry to the horizon 2025 and beyond. The outcome is not simply a scientific book, but a global perspective on the nascent field combining science, business, and strategic fundamentals. - Helps readers learn about the most current trends in cell-based therapy, their overall effectiveness from a clinical prospective, and how the industry is moving therapies forward for capitalization - Perspectives section at the end of each chapter summarizes key learnings, hypotheses, and objectives highlighted and combines scientific and business insights - Edited and authored by scientists representing both basic and clinical research and industry, presenting a complete story of the current state and future promise of cellular therapies |
| cold chain logistics in cell therapy: 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. |
| cold chain logistics in cell therapy: Parenteral Medications, Fourth Edition Sandeep Nema, John D. Ludwig, 2019-07-19 Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements |
| cold chain logistics in cell therapy: Oxford Handbook of Clinical and Healthcare Research Sumantra Ray, Sue Fitzpatrick, Rajna Golubic, Susan Fisher, 2016 This handbook is a definitive, up-to-date, and succinct text covering the legislative requirements, scientific foundations, and clinical good practice necessary for clinical, academic, and healthcare research. |
| cold chain logistics in cell therapy: Advanced Vaccination Technologies for Infectious and Chronic Diseases Vasso Apostolopoulos, Lalitkumar K. Vora, Vivek P. Chavda, 2024-03-25 The role of vaccines is emerging and even critical to ending infectious and chronic diseases and pandemics alike. The design and development of new vaccines could lead to improved health. Handbook on Advanced Vaccination Technologies for Infectious and Chronic Disease discusses these new developments and introduces the reader to the current state of the science and the outlook going forward from the discovery of vaccines to the clinical trials of personalized vaccines. Handbook on Advanced Vaccination Technologies for Infectious and Chronic Diseases is a valuable reference for occupational health professionals whose role involves supervision of immunization programs such as those working in the National Health Service, some sectors of higher education and the pharmaceutical industry. - Offers comprehensive coverage of different vaccine platforms and their development - Includes information on the regulatory perspective of vaccine development - Describes different delivery approaches for vaccinology - Explains the clinical development of vaccines along with novel platforms - Covers all recent developments of vaccine production technologies, new types of vaccines, and ongoing research that could prevent future pandemics |
| cold chain logistics in cell therapy: IAS Mains Paper 3 Technology Economic Development Bio Diversity Environment, Security & Disaster Management 2020 Mohit Sharma, Janmejay Sahni, Sujit Kumar, Yashwant Singh Rana, Dr. Priya Goel, 2019-11-12 UPSC is considered to be the most prestigious and toughest examination in the country. In order to crack these exams one need to do heavy preparations, thorough practice and clear concepts about each and every subject. “IAS Mains General Studies Paper – 3” the most updated study material incorporated with detailed information and supported by up-to-date facts and figures. The complete coverage on each topic of the syllabus have been divided into 4 Important Units in this book. It gives the complete depiction of Indian Economy and Agriculture, Science and Technology, Biodiversity, Environment and Disaster Management, and Internal Security. This book facilitates by giving the deep coverage on all topics of the syllabus at one place with the conceptual clarity to fulfil the need and demands of the aspirants, special exam oriented structure has been given according to the UPSC syllabus, discussion of the theoretical concepts with the contemporary examples are given, Solved Papers from Solved Papers 2019-17 and 16 and 3 Practice Sets that helps in raising up level of preparation. This book acts as a great help in achieving the success for the upcoming exam. TABLE OF CONTENTS Solved Paper 2019, Solved Paper 2018, and Solved Paper 2017, Unit 1: Indian Economy and Agriculture, Unit -2: Science and Technology, Unit -3: Biodiversity, Environment and Disaster Management, Unit -4: Internal Security, Solved Paper 2016, Practice Papers (1-3). |
| cold chain logistics in cell therapy: 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 |
| cold chain logistics in cell therapy: Therapy with Cultured Cells Howard Green, 2019-05-08 In this book the author describes the discoveries in his laboratory that led to therapy with cultured cells. The first cultured cell type used for therapy was the keratinocyte of the epidermis, for the treatment of burns. Subsequent developments led to the use of cultured cells for the treatment of diseases of the eye, of the joints and of other diseases. Cultured cells for therapy are now being prepared by industries in the US, Japan and Korea and are used in the aforesaid countries, as well as in France, Sweden and Greece, for the treatment of disease. |
| cold chain logistics in cell therapy: 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 |
| cold chain logistics in cell therapy: 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- |
| cold chain logistics in cell therapy: 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. |
| cold chain logistics in cell therapy: Transplantation, Bioengineering, and Regeneration of the Endocrine Pancreas Giuseppe Orlando, Lorenzo Piemonti, Camillo Ricordi, Robert J. Stratta, Rainer W.G. Gruessner, 2019-11-09 Transplantation, Bioengineering, and Regeneration of the Endocrine Pancreas, Volume 1, sets a new standard in transplant and regenerative medicine. The book details the-state-of-the-art in modern whole pancreas and islet transplantation, including donor selection, immunosuppression, complications, allograft pathology, and more. As regenerative medicine is changing the premise of solid organ transplantation, this volume catalogs the technologies being developed and the methods being implemented to bioengineer or regenerate the endocrine pancreas in order to more effectively treat diabetes. Edited and authored by unparalleled leaders in the field, this new volume argues for a much needed synergy between organ transplantation and regenerative medicine. - Provides comprehensive and cutting-edge knowledge of whole pancreas and islet transplantation - Includes sections that address donor selection, immunosuppression, complications, allograft pathology, and more - Offers an update on the progress of regenerative medicine research aimed at beta cells replacement in the treatment of diabetes |
| cold chain logistics in cell therapy: Progenitor and Stem Cell Technologies and Therapies Anthony Atala, 2012-03-15 Progenitor and stem cells have the ability to renew themselves and change into a variety of specialised types, making them ideal materials for therapy and regenerative medicine. Progenitor and stem cell technologies and therapies reviews the range of progenitor and stem cells available and their therapeutic application.Part one reviews basic principles for the culture of stem cells before discussing technologies for particular cell types. These include human embryonic, induced pluripotent, amniotic and placental, cord and multipotent stem cells. Part two discusses wider issues such as intellectual property, regulation and commercialisation of stem cell technologies and therapies. The final part of the book considers the therapeutic use of stem and progenitor cells. Chapters review the use of adipose tissue-derived stem cells, umbilical cord blood (UCB) stem cells, bone marrow, auditory and oral cavity stem cells. Other chapters cover the use of stem cells in therapies in various clinical areas, including lung, cartilage, urologic, nerve and cardiac repair.With its distinguished editor and international team of contributors, Progenitor and stem cell technologies and therapies is a standard reference for both those researching in cell and tissue biology and engineering as well as medical practitioners investigating the therapeutic use of this important technology. - Reviews the range of progenitor and stem cells available and outlines their therapeutic application - Examines the basic principles for the culture of stem cells before discussing technologies for particular cell types, including human embryonic, induced pluripotent, amniotic and placental, cord and multipotent stem cells - Includes a discussion of wider issues such as intellectual property, regulation and commercialisation of stem cell technologies and therapies |
| cold chain logistics in cell therapy: Handbook of Humanitarian Health Care Logistics George Mc Guire, 2015-10-31 |
| cold chain logistics in cell therapy: Advances in Biopreservation John G. Baust, John M. Baust, 2006-08-15 Moving rapidly from science fiction to science fact, cryopreservation is an integral part of many research, development, and production processes in industry and academia. The preservation sciences have emerged as an interdisciplinary platform that incorporates the fundamentals of cell and molecular biology, and bioengineering, with the classic met |
| cold chain logistics in cell therapy: Coping Effectively With Spinal Cord Injuries Paul Kennedy, 2008-10-20 For individuals who have suffered a spinal cord injury, it is a struggle to know how to assess and cope with such a life-changing event. The coping strategies that a person employs can have an enormous impact on their mental well-being and long-term health. Approach focused coping, in which the individual accepts and seeks to understand their condition, results in a sense of mastery, self-efficacy, and post traumatic growth. Conversely, avoidance focused coping can lead to anxiety, depression, self neglect, and substance abuse problems. Approximately 50% will meet the diagnostic criteria for depression at 6 months post injury. Research shows that those with depression will have a poorer outcome and shorter life-span. Coping effectiveness training (CET) aims to improve skills for assessing stress, teaching a range of coping skills that can be used to tackle stress, and provide an opportunity for interaction with others who have similar experiences of spinal cord injury. CET includes the identification of effective and ineffective responses to stress, especially those that are particularly unhelpful, such as disengagement, general avoidance, long term denial, and the expression of extreme emotion. By encouraging individuals to think critically about their behaviour in response to stressors, CET helps people avoid unproductive ways of coping. Like all TreatmentsThatWork programs, this treatment is evidence-based. In the author's clinical studies, CET has proven to successfully reduce levels of depression and anxiety in individuals with spinal cord injury, and also resulted in changes in negative self-perception and improved self-efficiacy. The intervention consists of seven, 60-75 minute sessions run two a week in small groups of six to nine people. By working in small groups, participants are able to share experience and build a community, reducing the sense of isolation that often results from sever injury. A corresponding workbook provides monitoring forms, homework exercises, and other user-friendly techniques to continue the work outside of therapy. TreatmentsThatWorkTM represents the gold standard of behavioral healthcare interventions! · All programs have been rigorously tested in clinical trials and are backed by years of research · A prestigious scientific advisory board, led by series Editor-In-Chief David H. Barlow, reviews and evaluates each intervention to ensure that it meets the highest standard of evidence so you can be confident that you are using the most effective treatment available to date · Our books are reliable and effective and make it easy for you to provide your clients with the best care available · Our corresponding workbooks contain psychoeducational information, forms and worksheets, and homework assignments to keep clients engaged and motivated · A companion website (www.oup.com/us/ttw) offers downloadable clinical tools and helpful resources · Continuing Education (CE) Credits are now available on select titles in collaboration with PsychoEducational Resources, Inc. (PER) |
| cold chain logistics in cell therapy: The Oxford Handbook of Business and the Natural Environment Pratima Bansal, Andrew J. Hoffman, 2012 This Handbook discusses the main issues, research, and theory on business and the natural environment, and how they impact on different business functions and disciplines |
| cold chain logistics in cell therapy: Next generation MSC therapy manufacturing, potency and mechanism of action analysis Raghavan Chinnadurai, Guido Moll, Sowmya Viswanathan, 2023-05-17 |
| cold chain logistics in cell therapy: Life in the Frozen State Barry J. Fuller, Nick Lane, Erica E. Benson, 2004-05-10 While it is barely 50 years since the first reliable reports of the recovery of living cells frozen to cryogenic temperatures, there has been tremendous growth in the use of cryobiology in medicine, agriculture, horticulture, forestry, and the conservation of endangered or economically important species. As the first major text on cryobiolog |
Common cold - Symptoms and causes - Mayo Clinic
May 24, 2023 · Typical signs and symptoms include earaches or the return of a fever following a common cold. Asthma. A cold can trigger wheezing, even in people who don't have asthma. …
Cold remedies: What works, what doesn't, what can't hurt
Jul 12, 2024 · Cold and cough medicines in young children. Cold and cough medicine you can get without a prescription can harm children. Do not give any cough and cold medicines to …
Common cold - Diagnosis and treatment - Mayo Clinic
May 24, 2023 · The science isn't clear on alternative cold remedies such as vitamin C, echinacea and zinc. Because studies of alternative cold remedies in children are limited, these remedies …
COVID-19, cold, allergies and the flu: What are the differences?
Nov 27, 2024 · There's no cure for the common cold. Treatment may include pain relievers and cold remedies available without a prescription, such as decongestants. Unlike COVID-19, a …
Common cold in babies - Symptoms & causes - Mayo Clinic
Apr 11, 2025 · A common cold can cause: Acute ear infection, called otitis media. This is the most common complication of the common cold. Ear infections occur when bacteria or viruses enter …
Mayo Clinic Q and A: Myths about catching a cold
Feb 10, 2022 · Cold ice cream can soothe a sore throat, and probiotics in yogurt can help alleviate stomach upset if you are taking antibiotics for an infection. Check with your primary health care …
Cold or allergy: Which is it? - Mayo Clinic
Feb 13, 2024 · A cold may last 3 to 10 days in adults, although a cough may last for a couple of weeks longer. You can treat the symptoms of the common cold with rest and added fluids. …
What to do if you get a respiratory infection: A Mayo Clinic …
Dec 30, 2024 · Flu symptoms include sore throat, runny or stuffy nose, fever, body aches and fatigue. These symptoms may overlap with other illnesses, like the common cold, but key …
Cold urticaria - Symptoms & causes - Mayo Clinic
May 6, 2025 · Cold urticaria (ur-tih-KAR-e-uh) is a reaction that appears within minutes after skin is exposed to the cold. Itchy welts, also called hives, arise on affected skin. Symptoms in …
Cold sore - Diagnosis and treatment - Mayo Clinic
Jan 5, 2024 · The cold sore ointment docosanol (Abreva) may shorten the healing time of a cold sore. At the first sign of symptoms, apply it to the affected skin as directed on the package. …
Common cold - Symptoms and causes - Mayo Clinic
May 24, 2023 · Typical signs and symptoms include earaches or the return of a fever following a common cold. Asthma. A cold can trigger wheezing, even in people who don't have asthma. …
Cold remedies: What works, what doesn't, what can't hurt
Jul 12, 2024 · Cold and cough medicines in young children. Cold and cough medicine you can get without a prescription can harm children. Do not give any cough and cold medicines to …
Common cold - Diagnosis and treatment - Mayo Clinic
May 24, 2023 · The science isn't clear on alternative cold remedies such as vitamin C, echinacea and zinc. Because studies of alternative cold remedies in children are limited, these remedies …
COVID-19, cold, allergies and the flu: What are the differences?
Nov 27, 2024 · There's no cure for the common cold. Treatment may include pain relievers and cold remedies available without a prescription, such as decongestants. Unlike COVID-19, a …
Common cold in babies - Symptoms & causes - Mayo Clinic
Apr 11, 2025 · A common cold can cause: Acute ear infection, called otitis media. This is the most common complication of the common cold. Ear infections occur when bacteria or viruses enter …
Mayo Clinic Q and A: Myths about catching a cold
Feb 10, 2022 · Cold ice cream can soothe a sore throat, and probiotics in yogurt can help alleviate stomach upset if you are taking antibiotics for an infection. Check with your primary health …
Cold or allergy: Which is it? - Mayo Clinic
Feb 13, 2024 · A cold may last 3 to 10 days in adults, although a cough may last for a couple of weeks longer. You can treat the symptoms of the common cold with rest and added fluids. …
What to do if you get a respiratory infection: A Mayo Clinic …
Dec 30, 2024 · Flu symptoms include sore throat, runny or stuffy nose, fever, body aches and fatigue. These symptoms may overlap with other illnesses, like the common cold, but key …
Cold urticaria - Symptoms & causes - Mayo Clinic
May 6, 2025 · Cold urticaria (ur-tih-KAR-e-uh) is a reaction that appears within minutes after skin is exposed to the cold. Itchy welts, also called hives, arise on affected skin. Symptoms in …
Cold sore - Diagnosis and treatment - Mayo Clinic
Jan 5, 2024 · The cold sore ointment docosanol (Abreva) may shorten the healing time of a cold sore. At the first sign of symptoms, apply it to the affected skin as directed on the package. …
