Vaccine Analysis: Strategies, Principles, and Control
Springer Berlin (Verlag)
978-3-662-45023-9 (ISBN)
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.
| Erscheint lt. Verlag | 9.12.2014 |
|---|---|
| Zusatzinfo | XII, 665 p. 124 illus., 76 illus. in color. |
| Verlagsort | Berlin |
| Sprache | englisch |
| Maße | 155 x 235 mm |
| Gewicht | 1178 g |
| 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 • Biosafety • Effective immune response • Infections • vaccines • Virus derived proteins |
| ISBN-10 | 3-662-45023-2 / 3662450232 |
| ISBN-13 | 978-3-662-45023-9 / 9783662450239 |
| Zustand | Neuware |
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