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Vaccine Analysis: Strategies, Principles, and Control

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 m...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Nunnally, Brian K. (Editor ), Turula, Vincent E. (Editor ), Sitrin, Robert D. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Berlin, Heidelberg : Springer Berlin Heidelberg : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Temas:
Acceso en línea:Texto Completo

MARC

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264 1 |a Berlin, Heidelberg :  |b Springer Berlin Heidelberg :  |b Imprint: Springer,  |c 2015. 
300 |a XII, 665 p. 124 illus., 76 illus. in color.  |b online resource. 
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505 0 |a 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. 
520 |a 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. 
650 0 |a Pharmacology. 
650 0 |a Immunology. 
650 0 |a Clinical biochemistry. 
650 1 4 |a Pharmacology. 
650 2 4 |a Immunology. 
650 2 4 |a Medical Biochemistry. 
700 1 |a Nunnally, Brian K.  |e editor.  |4 edt  |4 http://id.loc.gov/vocabulary/relators/edt 
700 1 |a Turula, Vincent E.  |e editor.  |4 edt  |4 http://id.loc.gov/vocabulary/relators/edt 
700 1 |a Sitrin, Robert D.  |e editor.  |4 edt  |4 http://id.loc.gov/vocabulary/relators/edt 
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