Springer Berlin Heidelberg, 2015. — 665 p. — ISBN 978-3-662-45024-6. — DOI 10.1007/978-3-662-45024-6.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.Content
1 Live Attenuated Viral Vaccines
2 Inactivated Viral Vaccines
3 Recombinant Virus-like Particle Protein Vaccines
4 Analysis of Influenza Vaccines
5 Live-Attenuated and Inactivated Whole-Cell Bacterial Vaccines
6 Analytical Control Strategy of Bacterial Subunit Vaccines
7 Bacterial Polysaccharide Vaccines: Analytical Perspectives
8 Glycoconjugate Vaccines
9 Vaccines in Research and Development: New Production Platforms and New Biomolecular Entities for New Needs
10 Role of Analytics in Viral Safety
11 Deep Sequencing Applications for Vaccine Development and Safety
12 Quality-by-Design: As Related to Analytical Concepts, Control and Qualification
13 Vaccine Potency Assays
14 Establishing a Shelf Life and Setting Lot-Release Specifications
15 Vaccine Reference Standards
16 Lot Release of Vaccines by Regulatory Authorities and Harmonization of Testing Requirements
17 Dendritic Cell Targeting Vaccines
