Conventional Test Method:

Potency Test of Hepatitis B Vaccine (Mouse)

Alternative Test Method:

Name & Description:

Serological Antigen Quantification

Immunochemical determination of antigen content with acceptance criteria validated against the in vivo test. Enzyme-linked immunosorbent assay (ELISA) and radio-immunoassay (RIA) using monoclonal antibodies specific for protection-inducing epitopes of Hepatitis B surface antigens (HBsAg) have been shown to be suitable. Suitable numbers of dilutions of the vaccine to be examined and the reference preparation are used and a parallel-line model is used to analyze the data which may be suitably transformed. Kits for measuring HBsAg in vitro are commercially available and it is possible to adapt their test procedures for use as an in vitro potency assay.

Validation Status:

No information

Regulatory Status:

EU: Accepted into PhEur ( 2.7.15)

Effect or Potential Effect on Animal Use:

Reduction

Refinement

References:
  • Council of Europe (CE) (2008) 2.7.6 Assay of Diphtheria vaccine (adsorbed). In: European Pharmacopoeia, 6th ed. Strasbourg, France: CE.
Information Last Reviewed:
May 2012