Development of Vaccines: From Discovery to Clinical Testing

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.

Spis treści:
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 Rappuol i
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 B iron–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

Nota biograficzna:
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.

Okładka tylna:
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.