Vaccine Analysis: Strategies, Principles, and Control

Przednia okładka
Brian K. Nunnally, Vincent E. Turula, Robert D. Sitrin
Springer, 27 lis 2014 - 665

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.

 

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Spis treści

1 Live Attenuated Viral Vaccines
1
2 Inactivated Viral Vaccines
45
3 Recombinant Viruslike Particle Protein Vaccines
81
4 Analysis of Influenza Vaccines
113
5 LiveAttenuated and Inactivated WholeCell Bacterial Vaccines
139
6 Analytical Control Strategy of Bacterial Subunit Vaccines
187
Analytical Perspectives
271
8 Glycoconjugate Vaccines
300
11 Deep Sequencing Applications for Vaccine Development and Safety
444
As Related to Analytical Concepts Control and Qualification
479
13 Vaccine Potency Assays
521
14 Establishing a Shelf Life and Setting LotRelease Specifications
542
15 Vaccine Reference Standards
563
16 Lot Release of Vaccines by Regulatory Authorities and Harmonization of Testing Requirements
573
17 Dendritic Cell Targeting Vaccines
597
Index
661

New Production Platforms and New Biomolecular Entities for New Needs
383
10 Role of Analytics in Viral Safety
397

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