Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. 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. Vaccines include a wide range of components including proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, and more. 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 considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students.
1. 1. Introduction to vaccine development - p. 1 2. 2. Overview of vaccine adjuvants - p. 9 3. 3. Formulation design considerations and good practice for live attenuated vaccine development - p. 27 4. 4. Subunit-based vaccines: challenges in developing protein-based vaccines - p. 79 5. 5. QbD approach to formulation development for protein-based vaccines - p. 137 6. 6. pDNA and mRNA vaccines - p. 157 7. 7. Antigen–adjuvant formulations—key considerations - p. 207 8. 8. Suspension properties and characterization of aluminum-adjuvanted vaccines - p. 225 9. 9. Effect of shipping stresses on suspension vaccines - p. 267 10. 10. Control strategy development guide for vaccine drug product - p. 279 11. 11. Lyophilized vaccine development - p. 297 12. 12. Conventional and nontraditional delivery methods and routes of vaccine administration - p. 329 13. Index - p. 357
Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. 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. Vaccines include a wide range of components including proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, and more. 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 considerations of vaccine production, this book is essential to formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students.
1. 1. Introduction to vaccine development - p. 1 2. 2. Overview of vaccine adjuvants - p. 9 3. 3. Formulation design considerations and good practice for live attenuated vaccine development - p. 27 4. 4. Subunit-based vaccines: challenges in developing protein-based vaccines - p. 79 5. 5. QbD approach to formulation development for protein-based vaccines - p. 137 6. 6. pDNA and mRNA vaccines - p. 157 7. 7. Antigen–adjuvant formulations—key considerations - p. 207 8. 8. Suspension properties and characterization of aluminum-adjuvanted vaccines - p. 225 9. 9. Effect of shipping stresses on suspension vaccines - p. 267 10. 10. Control strategy development guide for vaccine drug product - p. 279 11. 11. Lyophilized vaccine development - p. 297 12. 12. Conventional and nontraditional delivery methods and routes of vaccine administration - p. 329 13. Index - p. 357
