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Practical Aspects of Vaccine Development
- 1st Edition - September 8, 2021
- Editors: Parag Kolhe, Satoshi Ohtake
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 1 4 3 5 7 - 5
- eBook ISBN:9 7 8 - 0 - 1 2 - 8 1 4 3 5 8 - 2
Practical Aspects of Vaccine Development provides an academic and industry perspective on vaccine development and manufacturing. With the increasing complexity of vaccine products… Read more
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Request a sales quotePractical 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.
- 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
Formulation scientists, pharmacists, bioengineers, chemists or physicists in the pharmaceutical industry. Researchers and advanced students in pharmaceutical sciences
- Cover image
- Title page
- Table of Contents
- Copyright
- Contributors
- Preface
- Acknowledgments
- 1. Introduction to vaccine development
- Vaccines: the greatest advancement of modern medicine
- A brief historical review
- The foundation of vaccine development
- A summary of current strategies in vaccine development
- Adjuvants
- Summary
- 2. Overview of vaccine adjuvants
- Introduction
- General classification of vaccine adjuvants
- Specific types of adjuvants
- Future considerations in the development of adjuvants
- Conclusions
- 3. Formulation design considerations and good practice for live attenuated vaccine development
- Introduction
- Development of products with the end in mind
- Development by design
- Summary
- 4. Subunit-based vaccines: challenges in developing protein-based vaccines
- Introduction
- Similarities of vaccine proteins to therapeutic proteins
- Pneumococcal protein-based vaccine development
- Pneumococcal virulence factors
- Licensed pneumococcal vaccines
- Recombinant pneumococcal proteins as vaccine candidates
- Alternative approaches for pneumococcal vaccines
- Protective immunity against Chlamydia trachomatis
- Chlamydia trachomatis vaccine candidates
- Ricin vaccine candidates
- NoV vaccine candidates
- Clostridium difficile vaccine candidates
- 5. QbD approach to formulation development for protein-based vaccines
- Scope and challenges of protein bases formulation development
- Quality by design as a guiding principle in vaccine formulation development
- Preformulation studies
- Formulation development and optimization studies
- Conclusion
- 6. pDNA and mRNA vaccines
- Introduction
- Basic biology of pDNA and mRNA vaccines
- Nucleic acid vaccine development
- Process development; scalability and manufacturability
- The future of nucleic acid vaccines
- 7. Antigen–adjuvant formulations—key considerations
- Introduction
- Considerations for antigen–adjuvant compatibility
- Drug product design and considerations for dose preparation and administration
- Container closure
- Lyophilization of antigen–adjuvant formulation considerations
- Summary
- 8. Suspension properties and characterization of aluminum-adjuvanted vaccines
- Introduction
- Aluminum-containing adjuvant structure
- Principles of suspension behavior
- Properties and characterization
- Considerations in vaccine development
- Conclusion
- 9. Effect of shipping stresses on suspension vaccines
- Introduction
- Interplay between particle size, charge, and settling rate
- Effect of shipping stress on thermodynamic suspension stability
- Impact of individual shipping stresses on redispersion time
- Mitigation strategy to reduce high redispersion time
- Summary and recommendations
- 10. Control strategy development guide for vaccine drug product
- Introduction to control strategy approach
- Control strategy considerations
- Application of control strategy concept
- Raw material control strategy
- Summary and considerations for control strategy
- 11. Lyophilized vaccine development
- Introduction
- Overview of lyophilization formulation and process
- Vaccine-specific considerations
- Considerations for lyophilization cycle scale-up
- Summary
- 12. Conventional and nontraditional delivery methods and routes of vaccine administration
- The choice: the importance of the correct delivery system for an effective vaccination
- Conventional delivery methods: subcutaneous and intramuscular route
- Epidermis and dermis as new sites of vaccine delivery
- Other areas of the body as targets for vaccine delivery
- Conclusion
- Index
- No. of pages: 386
- Language: English
- Edition: 1
- Published: September 8, 2021
- Imprint: Academic Press
- Paperback ISBN: 9780128143575
- eBook ISBN: 9780128143582
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Parag Kolhe
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.
Affiliations and expertise
Biotherapeutics Pharmaceutical Sciences, Pfizer, Andover, MA, USASO
Satoshi Ohtake
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.
Affiliations and expertise
Biotherapeutics Pharmaceutical Sciences, Pfizer, Chesterfield, MO, USARead Practical Aspects of Vaccine Development on ScienceDirect