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Utilising successful case studies Vaccine Development will provide insight to the issues scientists face when producing a vaccine, the steps involved and will serve as an ideal reference tool regarding state-of-the-art vaccine development.
Designed with academic vaccine researchers in mind, this book presents a road map of how a vaccine develops from an idea in a researcher's imagination, to the lab bench, through preclinical evaluation, and into the clinic for safety and immunogenicity. The result of the editors' own efforts to glean practical information on the steps necessary to manufacture, bottle, and test their vaccines for clinical trials, this book provides answers to researcher questions such as: How do I identify antigens that would produce effective vaccines? Can I produce a clinical lot of vaccine in my laboratory? How should a vaccine be bottled? Which FDA expectations must I meet? What is an IND application and how do I file it? Which CFRs apply to production of a vaccine?
Development of Vaccines: From Discovery to Clinical Testing outlines the critical steps, and analytical tools and techniques, needed to take a vaccine from discovery through a successful clinical trial. Contributions from leading experts in the critical areas of vaccine expression, purification, formulation, pre-clinical testing and regulatory submissions make this book an authoritative collection of issues, challenges and solutions for progressing a biologic drug formulation from its early stage of discovery into its final clinical testing. A section with details and real-life experiences of toxicology testing and regulatory filing for vaccines is also included.
Vaccinology and Methods in Vaccine Research is a combination of cutting-edge methodologies, experimental approaches and literature reviews. The book covers all aspects of vaccine development, including basic immunology (focusing on the stimulation of adaptive immunity, which is required for vaccine efficacy), approaches to vaccine design and target validation, vaccine biomanufacturer and clinical development. Existing vaccinology resources are theoretical reference books, whereas this book provides a practical handbook for use in the research lab and classroom by those working in vaccinology and training others in the field. It is authored and edited by scientists actively engaged in vaccine research and development for day-to-day teaching/methodological advice. Addresses how to design a vaccine for an emerging disease, from a practical point-of -view, with chapters written by scientists who are grappling with these questions Provides new approaches to vaccine development. including vaccine targeting and virus-like-particle vaccines Gives up-to-date information and methodologies in use for vaccine adjuvants
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.
The past three decades have witnessed the development and regulatory approval of glycoconjugate vaccines against several medically important bacterial pathogens, including Haemophilus influenzae type b, Streptococcus pneumoniae, Neisseria meningitides, and Salmonella typhi. Immunologic protection against these and many other bacterial diseases is mediated through opsonophagocytic antibodies directed against the surface carbohydrates that define the bacterial serogroup or serotype and serve as virulence factors. These vaccines are composed of bacterial capsular polysaccharides chemically conjugated to immunogenic carrier proteins. Given that the diseases caused by these bacterial pathogens are most pronounced in infants and young children, the development of the glycoconjugate vaccine technology has had a considerable impact on public health. Many of the chapters in this volume were assembled as a follow-up from a symposium entitled "Carbohydrate-Based Vaccines and Adjuvants" which took place at the 254th American Chemical Society National Meeting held in Washington, DC (August 2017). The symposium was sponsored by Pfizer and the Carbohydrate (CARB) and Biotechnology (BIOT) divisions. This book, therefore, reflects the importance of this field toward design, development, manufacture and licensure of the complex carbohydrate-based (glycoconjugate) vaccines. The book has been organized into thirteen chapters, which cover a comprehensive landscape including the clinical history, design, development, chemistry, manufacturing and control (CMC) aspects, pre-clinical assays, adjuvants and the various approaches used to develop carbohydrate-based vaccines.
The Vaccine Book, Second Edition provides comprehensive information on the current and future state of vaccines. It reveals the scientific opportunities and potential impact of vaccines, including economic and ethical challenges, problems encountered when producing vaccines, how clinical vaccine trials are designed, and how to introduce vaccines into widespread use. Although vaccines are now available for many diseases, there are still challenges ahead for major diseases, such as AIDS, tuberculosis, and malaria. This book is designed for students, researchers, public health officials, and all others interested in increasing their understanding of vaccines. It answers common questions regarding the use of vaccines in the context of a rapidly expanding anti-vaccine environment. This new edition is completely updated and revised with new and unique topics, including new vaccines, problems of declining immunization rates, trust in vaccines, the vaccine hesitancy, and the social value of vaccines for the community vs. the individual child’s risk. Provides insights into diseases that could be prevented, along with the challenges facing research scientists in the world of vaccines Gives new ideas about future vaccines and concepts Introduces new vaccines and concepts Gives ideas about challenges facing public and private industrial investors in the vaccine area Discusses the problem of declining immunization rates and vaccine hesitancy
As well as being a reference for the design, analysis, and interpretation of vaccine studies, the text covers all design and analysis stages, from vaccine development to post-licensure surveillance, presenting likelihood, frequentists, and Bayesian approaches.
The Design and Development of Novel Drugs and Vaccines: Principles and Protocols presents both in silico methods and experimental protocols for vaccine and drug design and development, critically reviewing the most current research and emphasizing approaches and technologies that accelerate and lower the cost of product development. Sections review the technologies and approaches used to identify, characterize and establish a protein as a new drug and vaccine target, cover several molecular methods for in vitro studies of the desired target, and present various physiological parameters for in vivo studies. The book includes preclinical trials and research, along with information on FDA approval. Covers both in silico methods and experimental protocols for vaccine and drug development in a single, accessible volume Offers a holistic accounting of how developments in bioinformatics and large experimental datasets can be used in the development of vaccines and drugs Shows researchers the entire gamut of current therapies, ranging from computational inputs to animal studies Reviews the most current, cutting-edge research available on vaccine and drug design and development