Details

Development of Vaccines

From Discovery to Clinical Testing
1. Aufl.

von: Manmohan Singh, Indresh K. Srivastava
137,99 €
Verlag:	Wiley
Format:	PDF
Veröffentl.:	04.05.2011
ISBN/EAN:	9781118023624
Sprache:	englisch
Anzahl Seiten:	472

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Beschreibungen

Titelbeschreibung

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.

Inhaltsverzeichnis

PREFACE ix CONTRIBUTORS xi PART 1 IMMUNOGEN DESIGN 1 1 MICROBIAL VACCINE DESIGN: THE REVERSE VACCINOLOGY APPROACH 3 Roberto Rosini, Michele A. Barocchi, and Rino Rappuoli 2 DESIGN AND DEVELOPMENT OF RECOMBINANT VACCINES WITH VIRAL PROPERTIES 19 Gerd Lipowsky and Martin F. Bachmann 3 TOOLS FOR VACCINE DESIGN: PREDICTION AND VALIDATION OF HIGHLY IMMUNOGENIC AND CONSERVED CLASS II EPITOPES AND DEVELOPMENT OF EPITOPE-DRIVEN VACCINES 65 Anne S. De Groot, Matthew Ardito, Ryan Tassone, Paul Knopf, Leonard Moise, and William Martin PART 2 VACCINE PLATFORMS 95 4 VIRUS-LIKE PARTICLE VACCINES: ADVANTAGES AND CHALLENGES 97 Ted M. Ross, Nitin Bhardwaj, Hermancia S. Eugene, Brendan M. Giles, Sean P. McBurney, Shannan L. Rossi, Kirsten Schneider-Ohrum, and Xian-chun Tang 5 DESIGN PLATFORMS OF NANOCAPSULES FOR HUMAN THERAPEUTICS OR VACCINES 125 Masaaki Kawano, Li Xing, Kit S. Lam, Hiroshi Handa, Tatsuo Miyamura, Susan Barnett, Indresh K. Srivastava, and R. Holland Cheng 6 DESIGNING IMMUNOGENS FOR VACCINE DEVELOPMENT IN REFERENCE TO HIV 141 Aemro Kassa, Zohar Biron-Sorek, Pampi Sarkar, and Indresh K. Srivastava 7 EXPRESSION AND PURIFICATION OF RECOMBINANT PROTEINS FOR VACCINE APPLICATIONS 185 Carlo Zambonelli, Deeann Martinez-Guzmann, and Indresh K. Srivastava 8 DNA VACCINES FOR INFECTIOUS DIESASE 215 Samuel Stepenson, Manmohan Singh, and Indresh K. Srivastava 9 DEVELOPING STABLE CELL LINES FOR THE PRODUCTION OF VACCINE ANTIGENS 243 Xiaotian Zhong, Zhijian Lu, Richard Zollner, Jimin Zhang, Emily Braunstein, Narender Kalyan, and Maninder Sidhu PART 3 CHARACTERIZATION OF IMMUNOGENS 261 10 SPECTROSCOPY OF VACCINES 263 C. Russell Middaugh and Sangeeta B. Joshi 11 BIOPHYSICAL CHARACTERIZATION OF PROTEIN ANTIGENS WITHIN VACCINE FORMULATIONS 293 Padma Malyala, Derek O’Hagan, and Manmohan Singh PART 4 FORMULATION OPTIMIZATION AND STABILITY EVALUATION 305 12 STRUCTURAL CHARACTERISTICS PREDICT THE STABILITY OF HIV 307 Zohar Biron-Sorek, Yide Sun, Elaine Kan, Jeanne Flandez, Michael Franti, Jeffrey Ulmer, Susan Barnett, and Indresh K. Srivastava 13 SELECTION OF OPTIMAL ADJUVANTS AND PRODUCT FACTORS THAT AFFECT VACCINE IMMUNOGENICITY 327 Wei Wang and Manmohan Singh 14 LYOPHILIZATION AND STABILIZATION OF VACCINES 385 James Chesko, Chris Fox, Tim Dutill, Thomas Vedvick, and Steve Reed 15 EFFECT OF BUFFERS AND STABILIZERS ON VACCINE STABILITY AND EFFICACY 399 Shireesh P. Apte and Sydney O. Ugwu PART 5 CLINICAL AND MANUFACTURING ISSUES 415 16 SELECTION OF FINAL PRODUCT CONTAINERS 417 Luis Baez and Adrian Distler 17 FROM THE LAB TO THE CLINIC: FILING A PHASE I IND FOR AN INVESTIGATIONAL VACCINE 437 Kenneth G. Surowitz INDEX 451

Rezension

“Given the scarcity of books on this topic, this title will be a welcome addition to those with an interest in vaccine development, mostly researchers and students. It will be a useful reference for occupational health professionals whose role involves supervision of immunization programmes such as those working in the National Health Service, some sectors of higher education and the pharmaceutical industry.” (Journal of Occupational Medicine, 1 January 2013)

Autorenportrait

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.

Back cover copy

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: <ul> <li> Details all the tools needed for immunogen design and development </li> <li> Investigates vaccine platforms, including virus-like particles, nanocapsules, DNA vaccines, and protein expression and purification </li> <li> Explains the spectroscopy and biophysics techniques needed for accurate immunogen characterization </li> <li> Demonstrates how to optimize formulations and evaluate stability </li> <li> Details all the steps needed to file a new application for clinical vaccine testing </li> </ul> 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.