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.
Table of Contents
Section 1. Immunogen Design.
- Ch 1. Microbial Vaccines Design: The Reverse Vaccinology Approach (Roberto Rosini, Michèle A. Barocchi, Rino Rappuoli).
- Ch 2. Design and Development of Recombinant Vaccines with Viral Properties (Gerd Lipowsky, Martin F. Bachman).
- Ch 3. Tools for Vaccine Design: Prediction and Validation of Highly Immunogenic and Conserved Class II Epitopes and Development of Epitope-Driven Vaccines (Anne S. De Groot, Matthew Ardito, Ryan Tassone, Joseph Desrosiers, Paul Knopf, Leonard Moise, William Martin).
Section 2. Vaccine Platforms.
- Ch 4. Virus Like-Particle Vaccines advantages and Challenges (Ted M. Ross, Nitin Bhardwaj, Hermancia E. Eugene, Brendan M. Giles, Sean P. McBurney, Shannan L. Rossi, Kirsten Schneider-Ohrum, Xian-Chun Tang).
- Ch 5. Design Platforms of Nanocapsules for Human Therapeutics or Vaccines (Masaaki Kawano, Li Xing, Kit S. Lam, Hiroshi Handa, Tatsuo Miyamura, Susan Barnett, Indresh K. Srivastava and R. Holland Cheng).
- Ch 6. Designing Immunogens for Vaccine Development in Reference to HIV (Aemro Kassa, Zohar Biiron-Soreki, Pampi Sarkar, and Indresh K. Srivastava).
- Ch 7. Expression and Purfication of Recombinant Proteins for Vaccine Applications (Carlo Zambonelli, Deeann Martinez-Guzmann, and Indresh K. Srivastava).
- Ch 8. DNA Vaccines for Infectious disease (Samuel Stephenson, Manmohan Singh, Indresh K. Srivastava).
- Ch 9. Developing Stable Cell Lines for the Production of Vaccine Antigens (Xiaotian Zhong, Zhijian Lu, Richard Zollner, Jimin Zhang, Emily Braunstein, Narender Kalyan, and Maninder Sidhu).
Section 3. Characterization of Immunogens.
- Ch 10. Spectroscopy of Vaccines (C. Russell Middaugh, Sangeeta B. Joshi).
- Ch 11. Biophysical Characterization of Protein Antigens Within Vaccine Formulations (Padma Malyala, Derek O’Hagan, Manmohan Singh).
Section 4. Formulation optimization and stability evaluation.
- Ch 12. Structural Characteristics Predict the Stability of HIV (Zohar Biron, Yide Sun, Elaine Kan, Jeanne Flandez, Michael Franti, Jeffrey Ulmer, Susan Barnett, Indresh K. Srivastava).
- Ch 13. Selection of Optimal Adjuvants and Product Factors that Affect Vaccine Immunogenicity (Wei Wang, Manmohan Singh).
- Ch 14. Lyophilization and Stabilization of Vaccines (James Chesko, Chris Fox, Tim Dutill, Thomas Vedvick, Steve Reed).
- Ch 15. Effect of Buffers and Stabilizers on Vaccine Stability and Efficacy (Shireesh P. Apte, Sydney Ugwu).
Section 5. Clinical and manufacturing issues.
- Ch 16. Selection of Final Containers (Luis Baez, Adrian Distler).
- Ch 17. From The Lab to the Clinic: Filing a Phase I IND for an Investigational Vaccine (Kenneth G. Surowitz).