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.
journal_name
Vaccinejournal_title
Vaccineauthors
Little SF,Webster WM,Ivins BE,Fellows PF,Norris SL,Andrews GPdoi
10.1016/j.vaccine.2003.12.027subject
Has Abstractpub_date
2004-07-29 00:00:00pages
2843-52issue
21-22eissn
0264-410Xissn
1873-2518pii
S0264410X04000763journal_volume
22pub_type
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