Formulation, Development and Manufacturing of Vaccines: The Practical Aspects

Formulation, Development and Manufacturing of Vaccines: The Practical Aspects provides an industry perspective on vaccine product development and manufacture that covers their formulation development, manufacture and delivery/in-use considerations of vaccine production. 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 its challenges. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges, including the wide range of vaccine components that may comprise proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, etc. and the varying stability and behavior of solution- and suspension-based systems. This book is an essential resource for formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students. Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates and live vaccinesConsiders process development for solution, suspension and lyophilized productsExplores the future potential of vaccines, including multi-component vaccines and novel delivery mechanisms/devices INDICE: 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

• ISBN: 978-0-12-814357-5
• Editorial: Academic Press
• Encuadernacion: Rústica
• Páginas: 410
• Fecha Publicación: 01/05/2019
• Nº Volúmenes: 1
• Idioma: Inglés