Vaccine Analysis: Strategies, Principles, and Control

Brian K. Nunnally, Vincent E. Turula, Robert D. Sitrin (Herausgeber)

Buch | Softcover

XII, 665 Seiten

2016 | 1. Softcover reprint of the original 1st ed. 2015
Springer Berlin (Verlag)
978-3-662-52266-0 (ISBN)

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lt;p>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.

Erscheinungsdatum	16.09.2016
Zusatzinfo	XII, 665 p. 124 illus., 76 illus. in color.
Verlagsort	Berlin
Sprache	englisch
Maße	155 x 235 mm
Themenwelt	Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie
	Medizin / Pharmazie ► Pharmazie
	Studium ► Querschnittsbereiche ► Infektiologie / Immunologie
	Naturwissenschaften ► Biologie ► Biochemie
Schlagworte	Active pharmaceutical ingredient (API) • Bacterial derived proteins • biochemistry • Biomedical and Life Sciences • Biosafety • Effective immune response • immunology • Infections • medical biochemistry • Medical Research • Vaccine • vaccines • Virus derived proteins
ISBN-10	3-662-52266-7 / 3662522667
ISBN-13	978-3-662-52266-0 / 9783662522660
Zustand	Neuware