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In the case of rPAV, practical limitations prevented the finding of the best single dose for the potency testing of purified vaccines.
The inability of the current Epic® assay to consistently measure responses for different rHAs suggests that the current assay is best suited to quantify rHAs for research purposes and not for general potency testing of vaccines.
Although the lots tested in this study were not administered to U.S. personnel deployed during ODS/DS, the filling and potency testing of lot FAV 008 in March 1991 were contemporaneous with that of FAV 007 and were subject to the same regulatory criteria for lot release and use.
A low rate of virus isolation in tissues was found in mallards that died from infection of NDV Texas GB strain, a velogenic virus commonly used as a standard challenge virus in efficacy and potency testing of ND vaccines, and in research in the United States.
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Complexities of lethal challenge animal models have prompted the investigation of immunogenicity assays as potency tests of anthrax vaccines.
Data from 297 potency tests of FMD vaccines, comprising 4004 vaccinated cattle, performed at the FMD vaccine production facility in the Netherlands, were used for the present study.
We believe that assay specificity and the above characteristics are adequate to allow this ELISA to be considered for use in a mouse immunogenicity (potency) test of anthrax vaccines, and for the standardization of reagents.
Only in the case of the potency test of the purified mallein number 3 was there a point x reagent interaction.
Three different ELISAs quantifying rabies glycoprotein were evaluated as in vitro alternatives to the National Institutes of Health (NIH) in vivo potency test for batch release of human rabies vaccines.
In the case of BoNT LD50 potency testing, the dosing of animals is associated with severe suffering.
Nevertheless, the obvious benefits justify the ongoing efforts to overcome current challenges through research; mainly development of predictive islet potency tests, increase of islet availability, improvement of post-transplant monitoring, enhancement of islet engraftment and, most importantly, further development of less B-cell toxic immunosuppression regimens [ 65].
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