Vaccine Analysis: Strategies, Principles, and Control

• Corporate Author: SpringerLink (Online service)
• Other Authors: Nunnally, Brian K. (Editor), Turula, Vincent E. (Editor), Sitrin, Robert D. (Editor)
• Format: Electronic eBook
• Language: English
• Published: Berlin, Heidelberg : Springer Berlin Heidelberg : Imprint: Springer, 2015.
• Subjects: Medicine.; Immunology.; Vaccines.; Medical biochemistry.; Biomedicine.; Vaccine.; Medical Biochemistry.

 This book is an indispensable tool for anyone involved in the research, development, or manufacture of new or existing vaccines. It describes a wide array of analytical and quality control technologies for the diverse vaccine modalities. Topics covered include the application of both classical and modern bio-analytical tools; procedures to assure safety and control of cross contamination; consistent biological transition of vaccines from the research laboratory to manufacturing scale; whole infectious attenuated organisms, such as live-attenuated and inactivated whole-cell bacterial vaccines and antiviral vaccines using attenuated or inactivated viruses; principles of viral inactivation and the application of these principles to vaccine development; recombinant DNA approaches to produce modern prophylactic vaccines; bacterial subunit, polysaccharide and glycoconjugate vaccines; combination vaccines that contain multiple antigens as well as regulatory requirements and the hurdles of licensure. 

 Live Attenuated Viral Vaccines -- Inactivated Viral Vaccines -- Recombinant Virus Like Particle Protein Vaccines -- Analysis of influenza vaccines -- Live-attenuated and inactivated whole-cell bacterial vaccines -- Analytical control strategy of bacterial subunit vaccines -- Bacterial Polysaccharide Vaccines: Analytical Perspectives -- Glycoconjugate vaccines -- Vaccines in research and development: new production platforms and new biomolecular entities for new needs -- Role of Analytics In Viral Safety -- Deep Sequencing Applications for Vaccine Development and Safety -- Quality-by-design: As related to analytical concepts, control and qualification -- Vaccine Potency Assays -- Establishing a Shelf-life and Setting Lot-release Specifications -- Vaccine Reference Standards -- Lot Release of Vaccines by Regulatory Authorities and Harmonization of Testing Requirements -- Dendritic cell targeting vaccines.