Development of an in vitro-based potency assay for anthrax vaccine

Vaccine
Stephen F LittleGerard P Andrews

Abstract

The potency assay currently used to evaluate consistency of manufacture for the anthrax vaccine is contingent upon meeting specified parameters after statistical analysis of the percent survival and time to death of vaccinated guinea pigs after challenge with spores of a virulent strain of Bacillus anthracis. During the development of a new anthrax vaccine based upon recombinant protective antigen (rPA) adsorbed to aluminum hydroxide gel (Alhydrogel), we found that the serological response of female A/J mice, as measured by a quantitative anti-rPA IgG ELISA, may be an effective method to monitor a manufacturer's consistency for rPA-based vaccines. An advantage of the proposed in vitro-based potency assay is that it will not need stringent biosafety containment measures as required by the current guinea pig potency assay.

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Citations

Sep 1, 2005·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Stephen F Little
Aug 30, 2013·Expert Review of Vaccines·Manpreet KaurRakesh Bhatnagar
Sep 23, 2009·Expert Opinion on Biological Therapy·Dennis M KlinmanKoji Tomaru
Nov 10, 2012·Biologicals : Journal of the International Association of Biological Standardization·Rocío I Domínguez-CastilloJuan L Arciniega
Sep 22, 2015·Plant Biotechnology Journal·Stephen J StreatfieldVidadi Yusibov
Nov 20, 2012·Toxins·Stephanie AscoughDaniel M Altmann
Sep 5, 2014·Clinical and Vaccine Immunology : CVI·Ligong ChenConrad P Quinn
Apr 9, 2010·Clinical and Vaccine Immunology : CVI·Miriam M NgundiDrusilla L Burns
May 8, 2018·Biological Reviews of the Cambridge Philosophical Society·Colin J CarlsonNils C Stenseth
May 22, 2019·Microbiology Spectrum·Monika Ehling-SchulzTheresa M Koehler
Jun 25, 2015·Microbiology Spectrum·Susan WelkosChristopher Cote

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