作者: Cécile Sigoillot-Claude , Myriam Battaglio , Marc Fiorucci , Delphine Gillet , Anne-Sophie Vimort
DOI: 10.1016/J.VACCINE.2015.06.091
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摘要: Regulatory potency test for rabies vaccines requires mice vaccination followed by challenge with a live virus via intracerebral route. An alternative in vitro test, consistent the “3R's” (Reduce, Replace, Refine) was designed to quantify active glycoprotein G using seroneutralizing monoclonal antibodies. This versatile ELISA targets well conformed neutralizing epitopes. Therefore, it quantifies only trimeric pre-fusion form of known elicits production viral The makes possible antigen during all steps product cycle (i.e. cultivation, downstream process, formulation and stability presence aluminum gel or other vaccine valence). Moreover, batch-to-batch consistency our ingredients formulated products could be demonstrated.