Practical Aspects Of Vaccine Development

Book Description :

Formulation, Development and Manufacturing of Vaccines: The Practical Aspects provides an industry perspective on vaccine product development and manufacture that covers their formulation development, manufacture and delivery/in-use considerations of vaccine production. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and its challenges. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges, including the wide range of vaccine components that may comprise proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, etc. and the varying stability and behavior of solution- and suspension-based systems. This book is an essential resource for formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students. Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates and live vaccines Considers process development for solution, suspension and lyophilized products Explores the future potential of vaccines, including multi-component vaccines and novel delivery mechanisms/devices

Book Description :

This comprehensive, authoritative treatise covers all aspects of mucosal vaccines including their development, mechanisms of action, molecular/cellular aspects, and practical applications. The contributing authors and editors of this one-of-a-kind book are very well known in their respective fields. Mucosal Vaccines is organized in a unique format in which basic, clinical, and practical aspects of the mucosal immune system for vaccine development are described and discussed. This project is endorsed by the Society for Mucosal Immunology. Provides the latest views on mucosal vaccines Applies basic principles to the development of new vaccines Links basic, clinical, and practical aspects of mucosal vaccines to different infectious diseases Unique and user-friendly organization

Book Description :

Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and challenges being encountered. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges. Vaccines include a wide range of components including proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, and more. The container closure system may also be unique, and the product may require freezing storage or lyophilization based on the stability of the vaccine components. Based on the route of delivery, novel technologies and devices may be required. Covering formulation development, manufacture, and delivery considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students. Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates, and live vaccines Covers process development for solution, suspension, and lyophilized products Explores the future of vaccines, including multi-component vaccines and novel delivery mechanisms/devices

Book Description :

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.

Book Description :

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.

Book Description :

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

Book Description :

Mucosal Vaccines: Innovation for Preventing Infectious Diseases discusses basic knowledge and discovery in the area of mucosal immunology and its related scientific fields. This completely updated, revised and authoritative treatise covers all aspects of mucosal vaccines, including their development, mechanisms of action, molecular/cellular aspects and practical applications. The book is organized in a unique format with basic, clinical and practical aspects described and discussed. The accumulated knowledge and new discoveries on the development of mucosal vaccines are logically introduced and discussed in an easy-to-understand format. Provides the latest views on mucosal vaccines Applies basic and current principles in the field of mucosal immunology and related scientific fields (e.g., microbiology, infectious diseases, systems biology, medicine, dentistry, veterinary medicine and translational research) to the development of new vaccines Links basic, clinical and practical aspects of mucosal vaccines to different infectious diseases Presents user-friendly organization using attractive illustrations

Book Description :

Avian Immunology, Third Edition contains a detailed description of the avian innate immune system, encompassing the mucosal, enteric, respiratory and reproductive systems. The diseases and disorders it covers, include immunodepressive diseases and immune evasion, autoimmune diseases, and tumors of the immune system. Practical aspects of vaccination are examined as well. Extensive appendices summarize resources for scientists including cell lines, inbred chicken lines, cytokines, chemokines, and monoclonal antibodies. With contributions from the foremost international experts in the field, Avian Immunology 3rd, provides the most up-to-date crucial information not only for poultry health professionals and avian biologists, but also for comparative and veterinary immunologists, graduate students and veterinary students with an interest in avian immunology. Avian Immunology, Third Edition, is a fascinating and growing field and surely provides new and exciting insights for mainstream immunology in the future. Reflects significant advances in the field since the second edition, particularly the explosion of knowledge on genomics including work on the chicken, turkey and zebra finch genomes Provides a single source reference ranging from the basic science to cutting edge research Provides practical information for veterinarians particularly those specialised in poultry or companion bird medicine New chapters on the impact of the microbiome on the immune system, defence mechanisms in the egg and embryo and emerging transgene technologies

Book Description :

This volume provides a practical guide providing step-by-step methods and protocols on vaccine development and production. Divided into three volumes, Volume 3: Resources for Vaccine Development guides readers through chapters on vaccine adjuvants, vaccine vectors, production, vaccine delivery systems, vaccine bioinformatics, vaccine regulation, and intellectual property. Written in the format of the highly successful Methods in Molecular Biology series, each chapter includes an introduction to the topic, lists necessary materials and reagents, includes tips on troubleshooting and known pitfalls, and step-by-step, readily reproducible protocols. Authoritative and practical, Vaccine Design: Methods and Protocols, Second Edition, Volume 3: Resources for Vaccine Development aims to be a useful practical guide to researchers to help further their study in this field.

Book Description :

Immunopotentiators in Modern Vaccines provides an in-depth insight and overview of a number of most promising immunopotentiators in modern vaccines. In contrast to existing books on the subject it provides recent data on the critical mechanisms governing the activity of vaccine adjuvants and delivery systems. Knowledge of immunological pathways and scenarios of the cells and molecules involved is described and depicted in comprehensive illustrations. Contributions from leading international authorities in the field Well-illustrated, informative figures present the interactions between immunopotentiators and the host immune system Each chapter lists advantages and potential hurdles for achieving a practical application for the specific immunopentiator

Book Description :

The United States is facing a vaccine shortage that may threaten public health. This book examines vaccine research and development, production and supply, and utilization and offers recommendations aimed at ensuring vaccine supply and promoting innovation. In addition, this comprehensive volume provides information on the adverse reactions associated with the range of vaccines used in the United States and contains the most thorough analysis ever published on the state of the law regarding vaccine-related injury and compensation for vaccine injury.

Book Description :

The Vaccine Handbook has a simple purpose- to draw together authoritative information about vaccines into a simple and concise resource that can be used in the office, clinic, and hospital. Not an encyclopedia or scientific textbook, The Vaccine Handbook gives practical advice and provides enough background for the practitioner to understand the recommendations and explain them to his or her patients. For each vaccine, the authors discuss the disease and its epidemiology, the vaccine’s efficacy and safety, and the practical questions most frequently asked about the vaccine’s use. The authors also discuss problems such as allergies, breastfeeding, dosing intervals and missed vaccines, and immunocompromised individuals. This handbook is also available electronically for handheld computers. See Media listing for details.

Book Description :

In response to the coronavirus disease 2019 (COVID-19) pandemic and the societal disruption it has brought, national governments and the international community have invested billions of dollars and immense amounts of human resources to develop a safe and effective vaccine in an unprecedented time frame. Vaccination against this novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), offers the possibility of significantly reducing severe morbidity and mortality and transmission when deployed alongside other public health strategies and improved therapies. Health equity is intertwined with the impact of COVID-19 and there are certain populations that are at increased risk of severe illness or death from COVID-19. In the United States and worldwide, the pandemic is having a disproportionate impact on people who are already disadvantaged by virtue of their race and ethnicity, age, health status, residence, occupation, socioeconomic condition, or other contributing factors. Framework for Equitable Allocation of COVID-19 Vaccine offers an overarching framework for vaccine allocation to assist policy makers in the domestic and global health communities. Built on widely accepted foundational principles and recognizing the distinctive characteristics of COVID-19, this report's recommendations address the commitments needed to implement equitable allocation policies for COVID-19 vaccine.

Book Description :

Fish farming, in seawater and in freshwater, in cages, tanks or ponds, makes an ever-increasing and significant contribution to the production of aquatic food in many regions of the world. During the last few decades there has been significant progress and expansion in the aquaculture sector, characterized by intensified production and the exploitation of many new species. Aquaculture must be a sustainable bio-production, environmentally as well as economically. Disease prevention in order to reduce losses, and the use of antimicrobials is crucial in this perspective. Vaccination has, in a few years, become the most important method for disease prevention in aquaculture, and effective prophylaxis based on stimulation of the immune system of the fish is essential for further development of the industry. This book provides general information about disease prevention in fish by vaccination, as well as specific descriptions of the correct use of vaccines against the most important bacterial and viral infectious diseases of aquatic animals. The book is written by some of the world’s leading experts in the subject, drawn from many countries where aquaculture is a significant and expanding part of the economy. Fish Vaccination is an encyclopedia of fish vaccinology for every present and future aquaculturist. Professionals in the aquaculture sector, including fish veterinarians and fish biologists, within the industry, in scientific institutions and regulatory authorities will all find a huge wealth of commercially important knowledge within this book. Libraries in all universities where aquaculture, biological and veterinary sciences are studied and taught should have copies of this important book on their shelves.

Book Description :

Distinguished expert in vaccine development John Rhodes tells the story of the first approved COVID-19 vaccines and offers an essential, up-to-the-minute primer on how scientists discover, test, and distribute vaccines. As the COVID-19 pandemic has affected every corner of the world, changing our relationship to our communities, to our jobs, and to each other, the most pressing question has been—when will it end? Researchers around the globe are urgently trying to answer this question by racing to test and distribute a vaccine that could end the greatest public health threat of our time. In How to Make a Vaccine, an expert who has firsthand experience developing vaccines tells an optimistic story of how three hundred years of vaccine discovery and a century and a half of immunology research have come together at this powerful moment—and will lead to multiple COVID-19 vaccines. Dr. John Rhodes draws on his experience as an immunologist, including working alongside a young Anthony Fauci, to unravel the mystery of how vaccines are designed, tested, and produced at scale for global deployment. Concise and accessible, this book describes in everyday language how the immune system evolved to combat infection, how viruses responded by evolving ways to evade our defenses, and how vaccines do their work. That history, and the pace of current research developments, make Rhodes hopeful that multiple vaccines will protect us. Today the complex workings of the immune system are well understood. The tools needed by biomedical scientists stand ready to be used, and more than 160 vaccine candidates have already been produced. But defeating COVID-19 won’t be the end of the story: Rhodes describes how discoveries today are also empowering scientists to combat future threats to global health, including a recent breakthrough in the development of genetic vaccines, which have never before been used in humans. As the world prepares for a vaccine, Rhodes offers a current and informative look at the science and strategies that deliver solutions to the crisis.

Book Description :

Harnessing the Power of Viruses explores the application of scientific knowledge about viruses and their lives to solve practical challenges and further advance molecular sciences, medicine and agriculture. The book contains virus-based tools and approaches in the fields of: i) DNA manipulations in vitro and in vivo; ii) Protein expression and characterization; and iii) Virus- Host interactions as a platform for therapy and biocontrol are discussed. It steers away from traditional views of viruses and technology, focusing instead on viral molecules and molecular processes that enable science to better understand life and offer means for addressing complex biological phenomena that positively influence everyday life. The book is written at an intermediate level and is accessible to novices who are willing to acquire a basic level of understanding of key principles in molecular biology, but is also ideal for advanced readers interested in expanding their biological knowledge to include practical applications of molecular tools derived from viruses. Explores virus-based tools and approaches in DNA manipulation, protein expression and characterization and virus-host interactions Provides a dedicated focus on viral molecules and molecular processes that enable science to better understand life and address complex biological phenomena Includes an overview of modern technologies in biology that were developed using viral components/elements and knowledge about viral processes

Book Description :

The Public Health Foundation (PHF) in partnership with the Centers for Disease Control and Prevention (CDC) is pleased to announce the availability of Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition or “The Pink Book” E-Book. This resource provides the most current, comprehensive, and credible information on vaccine-preventable diseases, and contains updated content on immunization and vaccine information for public health practitioners, healthcare providers, health educators, pharmacists, nurses, and others involved in administering vaccines. “The Pink Book E-Book” allows you, your staff, and others to have quick access to features such as keyword search and chapter links. Online schedules and sources can also be accessed directly through e-readers with internet access. Current, credible, and comprehensive, “The Pink Book E-Book” contains information on each vaccine-preventable disease and delivers immunization providers with the latest information on: Principles of vaccination General recommendations on immunization Vaccine safety Child/adult immunization schedules International vaccines/Foreign language terms Vaccination data and statistics The E-Book format contains all of the information and updates that are in the print version, including: · New vaccine administration chapter · New recommendations regarding selection of storage units and temperature monitoring tools · New recommendations for vaccine transport · Updated information on available influenza vaccine products · Use of Tdap in pregnancy · Use of Tdap in persons 65 years of age or older · Use of PCV13 and PPSV23 in adults with immunocompromising conditions · New licensure information for varicella-zoster immune globulin Contact bookstore@phf.org for more information. For more news and specials on immunization and vaccines visit the Pink Book's Facebook fan page

Book Description :

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face when producing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up. Highlights include: Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies Authors from different major pharmaceutical and biotechnology companies Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market

Book Description :

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.

Book Description :

This book is a comprehensive resource on vaccines and immunizations for primary care physicians, advanced practice providers, and trainees. We are now seeing a rise in measles and the potential for rises in other previously rare infectious diseases, significantly due to public and physician misconceptions and misinformation about vaccines. The text addresses this issue by consolidating historical and current advances in vaccine science from how vaccines are developed to CDC recommendations on how and when to administer them. Expert authors also address barriers to improving vaccination rates in the U.S. and offer evidence-based recommendations on overcoming those barriers. This is an essential guide for primary care physicians, family physicians, pediatricians, internists, residents, medical students, mid-level providers, and learners for understanding vaccines and improving preventative care for their patients.