EUR USD GBP
+353-1-416-8900REST OF WORLD
1-800-526-8630U.S. (TOLL FREE)

Development of Vaccines. From Discovery to Clinical Testing

  • ID: 2171861
  • Book
  • July 2011
  • 472 Pages
  • John Wiley and Sons Ltd
1 of 4
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.

Note: Product cover images may vary from those shown
2 of 4
PREFACE ix

CONTRIBUTORS xi

PART 1 IMMUNOGEN DESIGN 1

1 MICROBIAL VACCINE DESIGN: THE REVERSE VACCINOLOGY APPROACH 3Roberto Rosini, Michele A. Barocchi, and Rino Rappuoli

2 DESIGN AND DEVELOPMENT OF RECOMBINANT VACCINES WITH VIRAL PROPERTIES 19Gerd 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 65Anne 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 97Ted 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 125Masaaki 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 141Aemro Kassa, Zohar Biron–Sorek, Pampi Sarkar, and Indresh K. Srivastava

7 EXPRESSION AND PURIFICATION OF RECOMBINANT PROTEINS FOR VACCINE APPLICATIONS 185Carlo Zambonelli, Deeann Martinez–Guzmann, and Indresh K. Srivastava

8 DNA VACCINES FOR INFECTIOUS DIESASE 215Samuel Stepenson, Manmohan Singh, and Indresh K. Srivastava

9 DEVELOPING STABLE CELL LINES FOR THE PRODUCTION OF VACCINE ANTIGENS 243Xiaotian Zhong, Zhijian Lu, Richard Zollner, Jimin Zhang, Emily Braunstein, Narender Kalyan, and Maninder Sidhu

PART 3 CHARACTERIZATION OF IMMUNOGENS 261

10 SPECTROSCOPY OF VACCINES 263C. Russell Middaugh and Sangeeta B. Joshi

11 BIOPHYSICAL CHARACTERIZATION OF PROTEIN ANTIGENS WITHIN VACCINE FORMULATIONS 293Padma Malyala, Derek O Hagan, and Manmohan Singh

PART 4 FORMULATION OPTIMIZATION AND STABILITY EVALUATION 305

12 STRUCTURAL CHARACTERISTICS PREDICT THE STABILITY OF HIV 307Zohar 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 327Wei Wang and Manmohan Singh

14 LYOPHILIZATION AND STABILIZATION OF VACCINES 385James Chesko, Chris Fox, Tim Dutill, Thomas Vedvick, and Steve Reed

15 EFFECT OF BUFFERS AND STABILIZERS ON VACCINE STABILITY AND EFFICACY 399Shireesh P. Apte and Sydney O. Ugwu

PART 5 CLINICAL AND MANUFACTURING ISSUES 415

16 SELECTION OF FINAL PRODUCT CONTAINERS 417Luis Baez and Adrian Distler

17 FROM THE LAB TO THE CLINIC: FILING A PHASE I IND FOR AN INVESTIGATIONAL VACCINE 437Kenneth G. Surowitz

INDEX 451

Note: Product cover images may vary from those shown
3 of 4

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)

Note: Product cover images may vary from those shown
4 of 4
Note: Product cover images may vary from those shown
Adroll
adroll