Conventional Test Method:

Lethal/Intradermal Challenge Test in the Batch Potency Testing of Diphtheria Vaccine (Methods A and B in PhEur 2.7.6)

Alternative Test Method:

Name & Description:

Vero Cell Assay for Potency testing of Diphtheria Vaccines

This method relies on metabolic inhibition or cytotoxicity as the end point, and on microscopic (cell morphology) or visual (colour) inspection of the cells. 

Validation Status:

EU: Norwegian Medicines Agency presently conducting validation

Regulatory Status:

EU: Accepted into PhEur

Effect or Potential Effect on Animal Use:

Reduction

Refinement

References:

• Winsnes R., Sesardic D., Daas A. and Behr-Gross M.E. (2004) Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines-part 1. Pharmeuropa Bio 2:35-68.
• Winsnes R., Sesardic D., Daas A. and Behr-Gross M.E. (2006) Collaborative study for the validation of serological methods for potency testing of diphtheria toxoid vaccines-part 2. Pharmeuropa Bio 1:73-88.

Information Last Reviewed:

May 2012