Practical Aspects of Vaccine Development

Table of Contents

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

Authors

Parag Kolhe Biotherapeutics Pharmaceutical Sciences, Pfizer, Andover, MA, USA. 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. Satoshi Ohtake Biotherapeutics Pharmaceutical Sciences, Pfizer, Chesterfield, MO, USA. 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.