Overview

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.

Full Product Details

Author:   Parag Kolhe (Biotherapeutics Pharmaceutical Sciences, Pfizer, Andover, MA, USA) ,  Satoshi Ohtake (Biotherapeutics Pharmaceutical Sciences, Pfizer, Chesterfield, MO, USA)
Publisher:   Elsevier Science Publishing Co Inc
Imprint:   Academic Press Inc
Weight:   0.810kg
ISBN:  

9780128143575

ISBN 10:   0128143576
Pages:   386
Publication Date:   08 September 2021
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   Temporarily unavailable  
The supplier advises that this item is temporarily unavailable. It will be ordered for you and placed on backorder. Once it does come back in stock, we will ship it out to you.

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

Reviews

Author Information

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.

Tab Content 6

Author Website:  

Customer Reviews

Recent Reviews

No review item found!

Add your own review!

Countries Available

All regions