Vaccine analysis : strategies, principles, and control
Brian K. Nunnally (Editor), Vincent E. Turula (Editor), Robert D. Sitrin (Editor)
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
1 online resource (xii, 665 pages) : illustrations (some color)
9783662450246, 3662450240
897377107
Printed edition:
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