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.
journal_name
Vaccinejournal_title
Vaccineauthors
Poirier B,Variot P,Delourme P,Maurin J,Morgeaux Sdoi
10.1016/j.vaccine.2009.12.006subject
Has Abstractpub_date
2010-02-17 00:00:00pages
1796-802issue
7eissn
0264-410Xissn
1873-2518pii
S0264-410X(09)01910-0journal_volume
28pub_type
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