Vaccine Manufacturing and Production will provide comprehensive information on the various fields involved in the production of vaccines, from fermentation, purification, formulation, to regulatory filing and facility designs. In recent years, there have been tremendous advances in all aspects of vaccine manufacturing. Improved technology and growth media have been developed for the production of cell culture with high cell density or fermentation. Improvements in large scale purification equipment have enabled the efficient processing of large biomasses. Novel adjuvants discovered in the past few years have shown great promises in human clinical trials by helping to elicit stronger immune response and provide long lasting memory effects. New concepts in facility designs have allowed for multiple use of the same facility. Vaccine Manufacturing and Production will serve as a reference on all aspects of vaccine production by providing an in-depth description of the available technologies for making different types of vaccines and the current thinking in facility designs and supply issues. This book will provide insight to the issues scientists face whenproducing a vaccine, the steps that are involved, and will serve as a reference tool regarding state-of-the-art vaccine manufacturing technologies and facility set-up.Emily Wen received her Ph.D. from Yale University in 2001 and is currently a Research Fellow at the Merck Research Laboratory in the department of Biological Development and Engineering. Dr. Wen has lead process developments for several major vaccine products from Phase I to Phase III clinical trials, including vaccines against hepatitis B, Haemophilus influenzae type b, Pneumococcal, Meningococcal, and Group B Streptococcus. She has also been responsible for purification and formulation process development. Her research interests are in process and analytical development, scale-up issues, and manufacturing quality.Ronald Ellis has championed or been project leader/co-leader for projects through multiple phases of development that became licensed products. Dr. Ellis became responsible for Mercks vaccine research and was cochairman of collaborations in developing pediatric combination vaccines with Pasteur-Merieux-Connaught (now Sanofi Pasteur) and CSL. He has directed the vaccine program at Astra Research Center Boston and started a Boston-area vaccine development subsidiary at BioChem Pharma that continued into Shire and ID Biomedical--he has servedon various international committees for vaccine research or development and presented data to regulatory agencies. Dr. Ellis is the founding Editor-in-Chief of the second peer-reviewed vaccine journal in the field and his technical expertise and knowledge are in all areas of biologics development including process, analytical, manufacturing quality, regulatory, clinical and strategy, aswell as in project management.
- ISBN: 978-0-470-26194-1
- Editorial: John Wiley & Sons
- Encuadernacion: Cartoné
- Páginas: 508
- Fecha Publicación: 23/04/2010
- Nº Volúmenes: 1
- Idioma: Inglés