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Practical Aspects of Vaccine Development
Academic Press Inc (Verlag)
978-0-12-814357-5 (ISBN)
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.
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 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
Erscheinungsdatum | 17.09.2021 |
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Verlagsort | San Diego |
Sprache | englisch |
Maße | 191 x 235 mm |
Gewicht | 810 g |
Themenwelt | Medizin / Pharmazie ► Pharmazie |
Studium ► Querschnittsbereiche ► Infektiologie / Immunologie | |
Studium ► Querschnittsbereiche ► Prävention / Gesundheitsförderung | |
Technik | |
ISBN-10 | 0-12-814357-6 / 0128143576 |
ISBN-13 | 978-0-12-814357-5 / 9780128143575 |
Zustand | Neuware |
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