Development of Vaccines

Leading experts guide you step by step to a successful clinical vaccine trial Development of Vaccines sets forth the issues and the challenges of vaccine development and the solutions needed to seamlessly advance a biologic drug formulation from discovery through all the essential steps that lead to a successful clinical vaccine trial. The authors skillfully guide you through everything you need to know, including current analytical tools and techniques, vaccine expression, purification, formulation, and preclinical testing. Not only does the book guide you through lab work, it also explains the regulatory submissions process, helping you gather and report the necessary data. Divided into five sections, this book serves as a reference to all the critical steps that take place from discovery to clinical trials: Details all the tools needed for immunogen design and development Investigates vaccine platforms, including virus-like particles, nanocapsules, DNA vaccines, and protein expression and purification Explains the spectroscopy and biophysics techniques needed for accurate immunogen characterization Demonstrates how to optimize formulations and evaluate stability Details all the steps needed to file a new application for clinical vaccine testing Each chapter of the book has been authored by one or more leading authorities with expertise spanning the critical areas of vaccine expression, purification, formulation, preclinical testing, and regulatory submission. Their contributions are not only based on a thorough review of the literature, but also their own hands-on lab bench experience, making this an unsurpassed guide to all stages of vaccine development.