Vaccine Analysis: Strategies, Principles, and Control (eBook)

Brian K. Nunnally, Vincent E. Turula, Robert D. Sitrin (Herausgeber)

eBook Download: PDF

2014 | 2015
XII, 665 Seiten
Springer Berlin (Verlag)
978-3-662-45024-6 (ISBN)

Infos

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.

Inhalt

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.

Produkt-Details

• Erscheint lt. Verlag: 27.11.2014
• Zusatzinfo: XII, 665 p. 124 illus., 76 illus. in color.
• Verlagsort: Berlin
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie ► Pharmazie
• Themenwelt: Studium ► 1. Studienabschnitt (Vorklinik) ► Biochemie / Molekularbiologie
• Themenwelt: Studium ► Querschnittsbereiche ► Infektiologie / Immunologie
• Schlagworte: Active pharmaceutical ingredient (API) • Bacterial derived proteins • Biosafety • Effective immune response • Infections • vaccines • Virus derived proteins
• ISBN-10: 3-662-45024-0 / 3662450240
• ISBN-13: 978-3-662-45024-6 / 9783662450246