E-grāmata: Vaccine Development and Manufacturing

Citing vaccine development as a complex process requiring multiple clinical trials to demonstrate product safety, efficacy, purity, potency, and consistency in manufacturing, Wen, Ellis, and Pujar and their international expert contributors provide comprehensive information on the various fields involved in the production of vaccines from fermentation, purification and formation to regulatory filing and facility design. They aim for a book that will be useful for a broad cross-section of biotechnology professionals, medical and biomedical scientists, and health care professionals. There are 15 chapters: history of vaccine process development; the production of Plasmid DNA vaccine in Escherichia coli; fungal expression systems for vaccine production; novel expression systems for vaccine production; viral vaccines purification; protein subunit vaccine purification; conjugate vaccine production technology; stabilization and formulation of vaccines; lyophilization in vaccine processes; strategies for heat-stable vaccines; production and characterization of aluminum-containing adjuvants; the biologics license application (BLA) in common technical document (CTD) format; the original new drug application (investigational new drug); facility design for vaccine manufacturing; vaccine production economics. Annotation ©2015 Ringgold, Inc., Portland, OR (protoview.com)

Vaccine Manufacturing and Production is an invaluable reference on how to produce a vaccine - from beginning to end - addressing all classes of vaccines from a processing, production, and regulatory viewpoint. It 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. 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 when producing 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.

Highlights include:

• Comprehensive coverage of vaccine production : from a process point of view- fermentation to purification to formulation developments; from a production point of view - from facility design to manufacturing; and from a regulatory point of view - requirements from government agencies
• Authors from different major pharmaceutical and biotechnology companies
• Describes the challenges and issues involved in vaccine production and manufacturing of the different classes of vaccines, an area not covered by other books currently on the market