Development of Vaccines: From Discovery to Clinical Testing

Manmohan Singh, Indresh K. Srivastava

ISBN: 9788126577590




This book 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




Part 1 Immunogen Design

1 Microbial Vaccine Design: The Reverse Vaccinology Approach
2 Design and Development of Recombinant Vaccines with Viral Properties
3 Tools for Vaccine Design: Prediction and Validation of Highly Immunogenic and Conserved Class Ii Epitopes and Development of Epitope-Driven Vaccines

Part 2 Vaccine Platforms

4 Virus-Like Particle Vaccines: Advantages and Challenges
5 Design Platforms of Nano capsules For Human Therapeutics or Vaccines
6 Designing Immunogens for Vaccine Development in Reference to HIV
7 Expression and Purification of Recombinant Proteins for Vaccine Applications
8 DNA Vaccines for Infectious Disease
9 Developing Stable Cell Lines for The Production of Vaccine Antigens

Part 3 Characterization of Immunogens

10 Spectroscopy of Vaccines
11 Biophysical Characterization of Protein Antigens Within Vaccine Formulations

Part 4 Formulation Optimization and Stability Evaluation

12 Structural Characteristics Predict the Stability of HIV
13 Selection of Optimal Adjuvants and Product Factors That Affect Vaccine Immunogenicity
14 Lyophilization And Stabilization of Vaccines
15 Effect of Buffers and Stabilizers on Vaccine Stability and Efficacy

Part 5 Clinical and Manufacturing Issues

16 Selection of Final Product Containers
17 From the Lab to The Clinic: Filing A Phase I IND For an Investigational Vaccine