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.
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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.About the Author:
Manmohan Singh, PhD, is currently working as the Global Head of Vaccine Formulation Science at Novartis Vaccines and Diagnostics in Cambridge, Massachusetts. Dr. Singh is a well-known expert in the areas of vaccine formulations and adjuvant research and has been working in vaccine R&D for the last twenty years. He has authored over 100 peer-reviewed manuscripts, review articles, and book chapters in this area. Dr. Singh is on the editorial board of seven international journals and has contributed to organizing several international vaccine conferences. He is also the editor of Vaccine Adjuvants and Delivery Systems (also published by Wiley).
Indresh K. Srivastava, PhD, is recognized as an expert in the field of vaccine research, particularly immunogen design, purification, and characterization of vaccines. He has been working in the field for more than twenty-five years; has published more than seventy-five scientific papers in peer-reviewed journals; and authored several reviews and book chapters. In addition, he has served on NIH special emphasis study sections focused on HIV Vaccines. He is on the editorial board of Current HIV Research, and is reviewer for ten international journals. After spending more than twelve years at Chiron/Novartis, Dr. Srivastava has joined the Vaccine Research Institute, NIAID/NIH, to lead the purification and analytical development of vaccine candidates. Prior to joining Chiron, he was an assistant professor (research) in microbiology and immunology, Medical College of Pennsylvania, Philadelphia.
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