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.
- Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates, and live vaccines
- Covers process development for solution, suspension, and lyophilized products
- Explores the future of vaccines, including multi-component vaccines and novel delivery mechanisms/devices
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. Conventional and non-traditional delivery methods and routes of administration 20. Combination product rule requirements for vaccines
Challenges and strategies 21. Potential of micro-needle based vaccine delivery 22. Challenges in assessing in-use stability of admixture (antigen-adjuvant mixture) prior to administration
Satoshi Ohtake, PhD, is an R&D professional with over 15 years of experience in the biotechnology industry, focusing on formulation and process development of various modalities ranging from small molecules to live attenuated vaccines. He has held positions of increasing responsibility at Nektar Therapeutics, Aridis Pharmaceuticals, and Pfizer. Dr. Ohtake is the inventor of over 10 patents and patent applications and author of over 40 peer-reviewed articles and book chapters. Additionally, he has delivered over 30 invited presentations. Dr. Ohtake received a B.S. from Caltech and a Ph.D. from the University of Wisconsin in Chemical Engineering. He is currently serving on the Journal of Pharmaceutical Sciences Editorial Advisory Board and the Caltech Alumni Association Board of Directors.
Parag Kolhe, PhD, is Senior Director at Pfizer biotherapeutic pharmaceutical sciences. He co-leads the formulation and process development group responsible for development of biotherapeutics modalities. He is an expert in biologics formulation, process development, tech transfer, PPQ, and control strategy approaches. Dr. Kolhe has broad product development knowledge ranging from early stage to commercial life cycle management products. He has developed various biologics modalities ranging from monoclonal antibodies, antibody drug conjugates, vaccines and more recently Chimeric Antigen T Cell therapy and gene therapy.