Description


Formulation, Development and Manufacturing of Vaccines: The Practical Aspects provides an industry perspective on vaccine product development and manufacture. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and challenges being encountered. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges, which include the wide range of vaccine components that may comprise of proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, etc,. and also the varying stability and behavior of solution- and suspension-based systems. The container closure system may also be unique and the product may require freezing storage or lyophilization based on the stability of the vaccine components. Based on the route of delivery, novel technologies and devices may be required. Covering formulation development, manufacture, and delivery/in-use considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students.



Key Features

•Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates, and live vaccines
•Considerations of process development for solution, suspension, and lyophilized products
•Exploration of future potential inlcuding multi-component vaccines and novel delivery mechanisms/devices



Readership


Formulation scientists, pharmacists, bioengineers, chemists or physicists in the pharmaceutical industry. Researchers and advanced students in pharmaceutical sciences

Section 1 Formulation Development
1. Introduction to vaccine formulation development
2. Overview of vaccine antigens
3. Overview of vaccine adjuvants
4. Formulation considerations for Live attenuated vaccines
5. Subunit based vaccines: Challenges in developing protein based vaccines
6. Subunit based vaccines: Challenges in developing polysaccharide based and conjugate vaccines
7. DNA vaccines
8. New frontiers in cancer vaccines
9. Adjuvant formulation development
10. Antigen-adjuvant formulation- Key considerations
11. Colloidal stability of suspension systems

Section 2 Process Development
12. Introduction to drug product process development for vaccines
13. Process development and scale up aspects for suspension vaccines
14. Effect of shipping stress on suspension vaccines
15. Developing control strategy for final dose concentration- Case study
16. Lyophilized vaccine development
17. Approaches for stabilizing vaccine antigens through spray drying
18. Regulatory requirements for drug product process: Lot consistency, process performance qualification and post approval changes

Section 3 Delivery
19. Combination product rule requirements for vaccines – Challenges and strategies
20. Potential of micro-needle based vaccine delivery
21. Challenges in assessing in-use stability of admixture (antigen-adjuvant mixture) prior to administration