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 vaccines
- Considers process development for solution, suspension and lyophilized products
- Explores the future potential 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. 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
Dr. Ohtake is an R&D professional with over 10 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, demonstrating capability to lead cross-functional teams to success. Adept at working in various environments with experience in small start-up as well as large global pharma. Dr. Ohtake is the inventor of over 10 patents and patent applications, author of over 30 articles in peer-reviewed journals and more than 15 invited presentations. He received his B.S. from Caltech and Ph.D. from the University of Wisconsin in Chemical Engineering. Currently serving on the Journal of Pharmaceutical Sciences Editorial Advisory Board and the Caltech Alumni Association Board of Directors.
Dr. Kolhe is an active leader and participant in the biotherapeutic community through the American Association of Pharmaceutical Sciences (AAPS) and The Pharmacists' Defence Association (PDA) as conference organizer, chair, moderator, invited speaker. He has expertise in the field of biotherapeutics and has developed, influenced and transformed control strategy approach into workable solution within Pfizer for biotherapeutics products. Dr. Kolhe has authored more than 18 peer reviewed journal articles, patents and been a book editor. He received his BE in Polymer Engineering from the University of Pune, India and his Ph.D. in Material Science and Engineering from Wayne State University, Detroit, USA.