http://www.loc.gov/mods/v3 http://www.loc.gov/standards/mods/v3/mods-3-2.xsd
Vaccine Analysis: Strategies, Principles, and Control
XII, 665 p. 124 illus., 76 illus. in color. online resource.
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.
edited by Brian K. Nunnally, Vincent E. Turula, Robert D. Sitrin.