Practical Aspects of Vaccine Development The Practical Aspects 1st Edition by Parag Kolhe, Satoshi Ohtake ISBN 0128143584 9780128143582

1. Introduction to vaccine development

Vaccines: the greatest advancement of modern medicine

A brief historical review

The foundation of vaccine development

A summary of current strategies in vaccine development

Adjuvants

Summary

2. Overview of vaccine adjuvants

Introduction

General classification of vaccine adjuvants

Specific types of adjuvants

Future considerations in the development of adjuvants

Conclusions

3. Formulation design considerations and good practice for live attenuated vaccine development

Introduction

Development of products with the end in mind

Development by design

Summary

4. Subunit-based vaccines: challenges in developing protein-based vaccines

Introduction

Similarities of vaccine proteins to therapeutic proteins

Pneumococcal protein-based vaccine development

Pneumococcal virulence factors

Licensed pneumococcal vaccines

Recombinant pneumococcal proteins as vaccine candidates

Alternative approaches for pneumococcal vaccines

Protective immunity against Chlamydia trachomatis

Chlamydia trachomatis vaccine candidates

Ricin vaccine candidates

NoV vaccine candidates

Clostridium difficile vaccine candidates

5. QbD approach to formulation development for protein-based vaccines

Scope and challenges of protein bases formulation development

Quality by design as a guiding principle in vaccine formulation development

Preformulation studies

Formulation development and optimization studies

Conclusion

6. pDNA and mRNA vaccines

Introduction

Basic biology of pDNA and mRNA vaccines

Nucleic acid vaccine development

Process development; scalability and manufacturability

The future of nucleic acid vaccines

7. Antigen–adjuvant formulations—key considerations

Introduction

Considerations for antigen–adjuvant compatibility

Drug product design and considerations for dose preparation and administration

Container closure

Lyophilization of antigen–adjuvant formulation considerations

Summary

8. Suspension properties and characterization of aluminum-adjuvanted vaccines

Introduction

Aluminum-containing adjuvant structure

Principles of suspension behavior

Properties and characterization

Considerations in vaccine development

Conclusion

9. Effect of shipping stresses on suspension vaccines

Introduction

Interplay between particle size, charge, and settling rate

Effect of shipping stress on thermodynamic suspension stability

Impact of individual shipping stresses on redispersion time

Mitigation strategy to reduce high redispersion time

Summary and recommendations

10. Control strategy development guide for vaccine drug product

Introduction to control strategy approach

Control strategy considerations

Application of control strategy concept

Raw material control strategy

Summary and considerations for control strategy

11. Lyophilized vaccine development

Introduction

Overview of lyophilization formulation and process

Vaccine-specific considerations

Considerations for lyophilization cycle scale-up

Summary

12. Conventional and nontraditional delivery methods and routes of vaccine administration

The choice: the importance of the correct delivery system for an effective vaccination

Conventional delivery methods: subcutaneous and intramuscular route

Epidermis and dermis as new sites of vaccine delivery

Other areas of the body as targets for vaccine delivery

Conclusion

Index