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Vaccine Analysis: Strategies, Principles, and Control

  • Book
  • © 2015

Overview

Editors:
  1. Brian K. Nunnally

    1. Apex, USA

  2. Vincent E. Turula

    1. Pfizer BioTherapeutics Pharmaceutical Sc, Pearl River, USA

  3. Robert D. Sitrin

    1. Sitrin Solutions, Lafayette Hill, USA

  • Equips readers to handle the complex analysis of vaccines
  • Treats both research and application aspects
  • Describes analytical and quality control technologies
  • Includes supplementary material: sn.pub/extras

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About this book

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.

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Table of contents (17 chapters)

  1. Front Matter

    Pages i-xii
    Download chapter PDF

  2. Live Attenuated Viral Vaccines

    • Mark S. Galinski, Kuldip Sra, John I. Haynes II, Jennifer Naspinski
    Pages 1-44

  3. Inactivated Viral Vaccines

    • Barbara Sanders, Martin Koldijk, Hanneke Schuitemaker
    Pages 45-80

  4. Recombinant Virus-like Particle Protein Vaccines

    • Robert D. Sitrin, Qinjian Zhao, Clinton S. Potter, Bridget Carragher, Michael W. Washabaugh
    Pages 81-112

  5. Analysis of Influenza Vaccines

    • Pierre-Alain Moisset, Jeffrey Pederson, Nathalie Landry
    Pages 113-137

  6. Live-Attenuated and Inactivated Whole-Cell Bacterial Vaccines

    • Anita H. J. van den Biggelaar, Jan T. Poolman
    Pages 139-186

  7. Analytical Control Strategy of Bacterial Subunit Vaccines

    • Shwu-Maan Lee, Vincent Turula, Bradford Powell, Mikkel Nissum, Mariagrazia Pizza, Claudia Magagnoli et al.
    Pages 187-270

  8. Bacterial Polysaccharide Vaccines: Analytical Perspectives

    • Earl Zablackis, Philippe Talaga, Suddham Singh
    Pages 271-299

  9. Glycoconjugate Vaccines

    • Neil Ravenscroft, Paolo Costantino, Philippe Talaga, Roberto Rodriguez, William Egan
    Pages 301-381

  10. Vaccines in Research and Development: New Production Platforms and New Biomolecular Entities for New Needs

    • John P. Hennessey Jr., Niranjan Y. Sardesai
    Pages 383-396

  11. Role of Analytics in Viral Safety

    • Rebecca L. Sheets, Paul A. Duncan
    Pages 397-443

  12. Deep Sequencing Applications for Vaccine Development and Safety

    • David Onions, Colette Côté, Brad Love, John Kolman
    Pages 445-477

  13. Quality-by-Design: As Related to Analytical Concepts, Control and Qualification

    • Beth Junker, Earl Zablackis, Thorsten Verch, Tim Schofield, Pierre Douette
    Pages 479-520

  14. Vaccine Potency Assays

    • Todd Ranheim, Ned Mozier, William Egan
    Pages 521-541

  15. Establishing a Shelf Life and Setting Lot-Release Specifications

    • William Egan, Timothy Schofield
    Pages 543-562

  16. Vaccine Reference Standards

    • Brian K. Nunnally
    Pages 563-572

  17. Lot Release of Vaccines by Regulatory Authorities and Harmonization of Testing Requirements

    • Rajesh K. Gupta, Chander K. Gupta, Laurent Mallet
    Pages 573-596

  18. Dendritic Cell Targeting Vaccines

    • Yoonkyung Do, Bradford Powell
    Pages 597-659

  19. Back Matter

    Pages 661-665
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Editors and Affiliations

  • Apex, USA

    Brian K. Nunnally

  • Pfizer BioTherapeutics Pharmaceutical Sc, Pearl River, USA

    Vincent E. Turula

  • Sitrin Solutions, Lafayette Hill, USA

    Robert D. Sitrin

Accessibility Information

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Bibliographic Information

  • Book Title: Vaccine Analysis: Strategies, Principles, and Control

  • Editors: Brian K. Nunnally, Vincent E. Turula, Robert D. Sitrin

  • DOI: https://doi.org/10.1007/978-3-662-45024-6

  • Publisher: Springer Berlin, Heidelberg

  • eBook Packages: Biomedical and Life Sciences, Biomedical and Life Sciences (R0)

  • Copyright Information: Springer-Verlag Berlin Heidelberg 2015

  • Hardcover ISBN: 978-3-662-45023-9Published: 09 December 2014

  • Softcover ISBN: 978-3-662-52266-0Published: 10 September 2016

  • eBook ISBN: 978-3-662-45024-6Published: 27 November 2014

  • Edition Number: 1

  • Number of Pages: XII, 665

  • Number of Illustrations: 48 b/w illustrations, 76 illustrations in colour

  • Topics: Vaccine, Immunology, Medical Biochemistry

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