Validation of a new alternative for determining in vitro potency in vaccines containing Hepatitis B from two different manufacturers.

Facing the discontinuation of the Auszyme kit, an alternative is needed for determining the in vitro potency of Hepatitis B surface antigen in vaccines. An inhibition ELISA has already proven to be reliable, but not in vaccine combinations. We validated this method by the evaluation of monovalent and combined vaccines from two different manufacturers. All validation parameters fulfilled the defined acceptance criteria. There was some interference with Hepatitis B potency, mainly produced by the whole cell Pertussis component, but it was not significant. A significant correlation between the Auszyme kit and the in vivo method was observed. We demonstrated that our ELISA is suitable for evaluating HB antigen in vaccines and could be considered as a potential alternative to the Auszyme kit.