Practical Aspects of Vaccine Development

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, 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.

• Section 1: Formulation Development1. Overview of vaccine antigensKatherine Elizabeth Odneal2. Overview of vaccine adjuvantsMansoor M. Amiji, Rushit Lodaya, Sonia Gregory and Derek t. O’Hagan3. Formulation considerations for Live attenuated vaccinesLee Smith4. Subunit based vaccines: Challenges in developing protein based vaccinesCharkes Middaugh and Salvador Fernando Ausar5. Formulation development approaches and considerations for protein based vaccinesMalte Meppen and Daniela Stranges6. DNA and RNA vaccinesKanwal Gill, Leanne Minall and Aslin Rodriguez Nassif7. Antigen-adjuvant formulation- Key considerationsDeep Bhattacharya, Aaron J. Latal, Vamsi Krishna Mudhivarthi and Chris Wiley II8. Suspension Properties and Characterization of Aluminum-Adjuvanted VaccinesAlex LangfordSection 2: Process Development 9. Effect of shipping stress on suspension vaccinesJianxin Guo and Parag Kolhe10. Developing control strategy for final dose concentration- Case study Deep Bhattacharya and Parag Kolhe11. Lyophilized vaccine developmentAdora Padilla, Nicole Payton and Rushit LodayaSection 3: Delivery12. Conventional and non-traditional delivery methods and routes of administrationRoberta Antonia Diotti, Giuseppe Andrea Sautto and Valeria Caputo