Practical Aspects Of Vaccine Development

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

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

In December 1991, at FAO Headquarters in Rome, the Animal Production and Health Division held an Expert Consultation in the Quality Control of Veterinary Vaccines in Developing Countries. The purpose of the consultation was to bring together experts in various aspects of vaccine production and quality control, to consider existing problems and likely future developments in the application of vaccines for the control of animal disease and to make recommendations in this important field. The consultation recommended that FAO lead the way in forging a closer cooperation among international organizations in the development of a more coherent approach to vaccine quality control; this manual is FAO s response to that recommendation. Written by some of the most highly regarded international experts in the field, the manual is principally concerned with providing guidelines and recommendations for the application of modern methods of vaccine production and evaluation, and also presents information on the state of veterinary vaccine development. Contents: Part I: Overview: The Present State of Veterinary Vaccine Development Chapter 1: The Introduction of Immunity by Veterinary Immunoprophylactics by W I Morrison, Chapter 2: Genetically Engineered Vaccines by B W J Mahy, Chapter 3: Viral Vaccines by F Brown, Chapter 4: Bacterial Vaccines by P D Walker, Chapter 5: Mycoplasmal Vaccines by A Provost, Chapter 6:Protozoal and Rickettsial Vaccines by A J DeVos, E Pipano, F Muissi and W K Jorgenesn, Chapter 7: Multicellular Parasite Vaccines by J B McKeand and D P Knox, Poultry Vaccines (1) Chapter 8: Conventional Vaccines by J B McFerran, Poultry Vaccines (2) Chapter 9: Special Requirements for Village Chickens by R P Spradbrow, Chapter 10: Fish Vaccines by A Adams, K D Thompson and R J Roberts, Chapter 11: Role of the Office International des Epizooties and International Organizations in Vaccine Quality Standardization by M Truszcynski and J Blancou. Part II: Planning and Management of Vaccine Production Chapter 12: Registration, Licensing, Controls and Practical Issues Related to Veterinary Vaccines by P Vannier, Chapter 13: The Role of Private Industry in the Transfer of Vaccine Tecnology to Developing Countries by A J B Haigh, Chapter 14: General Design and Operating Requirements for Vaccine Manufacturing Establishments by P J Radlett, Chapter 15: Design, Repair and Maintenance of Vaccine Manufacturing Establishments and Equipment by J Estefanell and L Mesopir, Chapter 16: Aspects of Financial Management of Vaccine Manufacturing Operations in Developing Countries by P deGreve, Chapter 17: The Logistics of Vaccine Manufacture in Developing Countries by P Hunter. Part III: Production Operations Chapter 18: Basic Laboratory Services and Media Preparation for Vaccine Production by E E Worrall, Chapter 19: Modern Cell Culture Technology for Vaccine Manufacture by P J Radlett, Chapter 20: Fermentation Technology for the Production of Bacterial Vaccines by F Bover, Chapter 21: The Use of Lyophilization in the Manufacture of Vaccines by J C Mariner, Inactivation of Antigents for Veterinary Vaccines (1) Chapter 22: Viral Vaccines by H G Bahnemann, Inactivation of Antigents for Veterinary Vaccines (2) Chapter 23: Bacterial Vaccines, Chapter 24: Adjuvants in Veterinary Vaccines by R Bomford, Chapter 25: Bottling, Labelling and Packaging of Vaccines by V A Srinivasan, A P Kariath and P B V P Bangar Raju. Part IV: Quality Assurance and Quality Control Chapter 26: Quality Assurance and Good Manufacturing Practice by J P Soulebot, V J Palya, M Rweyemamu and D Sylla, Chapter 27: The Principles of Good Laboratory Practices, Including Safety in Vaccines Production and Quality Control by C A Mebus, Chapter 28: The Role of Reference and Regional Laboratories by A I Donaldson and V Astudillo, Chapter 29: Description and Documentation of Production and Quality Control of Veterinary Vaccines by S Ullah and G Blocks, Chapter 30: Assessment of Potency in Bacterial Vaccines by P A Knight, Chapter 31: Potency Control of Modified Live Viral Vaccines by C Terpstra, Chapter 32: Potency Assessment of Inactivated Viral Vaccines by T R Doel, Chapter 33: In Vitro Potency Testing of Inactivated Biologics: Current Situation in the European Union by J P Soulebot, F Milward and P Prevost, Chapter 34: Sterility Management and Testing of Vaccines and Raw Materials for Adventitious Agents by G Blocks.

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.

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

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.

This volume provides a practical guide providing step-by-step protocol to design and develop vaccines for human diseases. Divided into three volumes, Volume 1: Vaccines for Human Diseases guides readers through an introductory section on future challenges for vaccinologists and the immunological mechanism of vaccines. Chapters focus on design of human vaccines for viral, bacterial, fungal, and parasitic diseases as well as tumor vaccines. 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 1: Vaccines for Human Diseases aims to be a useful practical guide to researchers to help further their study in this field.

SMART Vaccines - Strategic Multi-Attribute Ranking Tool for Vaccines - is a prioritization software tool developed by the Institute of Medicine that utilizes decision science and modeling to help inform choices among candidates for new vaccine development. A blueprint for this computer-based guide was presented in the 2012 report Ranking Vaccines: A Prioritization Framework: Phase I. The 2013 Phase II report refined a beta version of the model developed in the Phase I report. Ranking Vaccines: Applications of a Prioritization Software Tool: Phase III: Use Case Studies and Data Framework extends this project by demonstrating the practical applications of SMART Vaccines through use case scenarios in partnership with the Public Health Agency of Canada, New York State Department of Health, and the Serum Institute of India. This report also explores a novel application of SMART Vaccines in determining new vaccine product profiles, and offers practical strategies for data synthesis and estimation to encourage the broader use of the software.