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Practical Aspects of Vaccine Development

A review of the current state-of-the-vaccine development industry and challenges encountered

Parag Kolhe (Edited by), Satoshi Ohtake (Edited by)

9780128143575

Paperback / softback, published 8 September 2021

386 pages
23.4 x 19 x 2.5 cm, 0.81 kg

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.

Section 1: Formulation Development

1. Overview of vaccine antigens

Katherine Elizabeth Odneal

2. Overview of vaccine adjuvants

Mansoor M. Amiji, Rushit Lodaya, Sonia Gregory and Derek t. O’Hagan

3. Formulation considerations for Live attenuated vaccines

Lee Smith

4. Subunit based vaccines: Challenges in developing protein based vaccines

Charkes Middaugh and Salvador Fernando Ausar

5. Formulation development approaches and considerations for protein based vaccines

Malte Meppen and Daniela Stranges

6. DNA and RNA vaccines

Kanwal Gill, Leanne Minall and Aslin Rodriguez Nassif

7. Antigen-adjuvant formulation- Key considerations

Deep Bhattacharya, Aaron J. Latal, Vamsi Krishna Mudhivarthi and Chris Wiley II

8. Suspension Properties and Characterization of Aluminum-Adjuvanted Vaccines

Alex Langford

Section 2: Process Development

9. Effect of shipping stress on suspension vaccines

Jianxin Guo and Parag Kolhe

10. Developing control strategy for final dose concentration- Case study

Deep Bhattacharya and Parag Kolhe

11. Lyophilized vaccine development

Adora Padilla, Nicole Payton and Rushit Lodaya

Section 3: Delivery

12. Conventional and non-traditional delivery methods and routes of administration

Roberta Antonia Diotti, Giuseppe Andrea Sautto and Valeria Caputo

Subject Areas: Pharmacology [MMG], Immunology [MJCM], Public health & preventive medicine [MBN], Pharmaceutical industries [KNDP]

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