1.
Vaccine
; 28(7): 1796-802, 2010 Feb 17.
Article
in English
| MEDLINE
| ID: mdl-20018270
ABSTRACT
Since many years Afssaps applies the 3R's strategy (replacement, reduction and refinement) for the use of laboratory animal testing in the framework of vaccine batch release. In this context, for Hepatitis A vaccines, a study was carried out to assess the feasibility of replacing the in vivo "Gold Standard" potency assay by the Afssaps' validated in-house antigen content in vitro assay on routine testing. The use of a panel of potent vaccine batches and reduced-potency samples by heating demonstrated a correlation between the two methods. This encourages Afssaps to progressively switch from in vivo to in vitro assay in the framework of Hepatitis A vaccines batch release.