| Subject |
Vaccines -- Testing.
|
|
Vaccines industry -- Quality control.
|
|
Analytical chemistry.
|
|
Vaccines -- chemistry.
|
|
Chemistry Techniques, Analytical.
|
| Alt Name |
Nunnally, Brian K.,
|
|
Turula, Vincent E.,
|
|
Sitrin, Robert D.,
|
| Description |
1 online resource (xii, 665 pages) : illustrations (some color) |
|
polychrome rdacc |
| Bibliography Note |
Includes bibliographical references and index. |
| Contents |
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. |
| Summary |
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. |
| Note |
Online resource; title from PDF title page (ScienceDirect, viewed January 30, 2015). |
| ISBN |
9783662450246 (electronic bk.) |
|
3662450240 (electronic bk.) |
|
9783662450239 |
|
3662450232 |
| ISBN/ISSN |
10.1007/978-3-662-45024-6 |
| OCLC # |
897377107 |
| Additional Format |
Printed edition: 9783662450239 |
|
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