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Title Vaccine analysis : strategies, principles, and control / Brian K. Nunnally, Vincent E. Turula, Robert D. Sitrin, editors.
Imprint Heidelberg : Springer, [2015]

View online
View online
Subject Vaccines -- Testing.
Vaccines industry -- Quality control.
Analytical chemistry.
Vaccines -- chemistry.
Chemistry Techniques, Analytical.
Alt Name Nunnally, Brian K.,
Turula, Vincent E.,
Sitrin, Robert D.,
Description 1 online resource (xii, 665 pages) : illustrations (some color)
polychrome rdacc
Bibliography Note Includes bibliographical references and index.
Contents 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.
Summary 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.
Note Online resource; title from PDF title page (ScienceDirect, viewed January 30, 2015).
ISBN 9783662450246 (electronic bk.)
3662450240 (electronic bk.)
ISBN/ISSN 10.1007/978-3-662-45024-6
OCLC # 897377107
Additional Format Printed edition: 9783662450239

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