Collaborative study for the establishment of erysipelas ELISA coating antigen. European Biological Reference...

The development and validation of suitable alternatives for the replacement of in vivo challenge testing in the evaluation of vaccines is an important goal for national authorities and manufacturers involved in the assessment of quality, safety and efficacy of such products. To that end, 13 laboratories from 9 European countries, including 5 manufacturers, 7 authorities and EDQM, have taken part in a collaborative study to evaluate the suitability of a candidate reference preparation of erysipelas coating antigen for ELISA as a European Pharmacopoeia Biological Reference Preparation (Ph. Eur. BRP No. 1). The new Ph. Eur. BRP is intended for use in a serological assay, which would significantly reduce the suffering of animals in the potency assays of inactivated erysipelas vaccines. Participants were provided with sufficient study material, including the candidate coating antigen, and a panel of test sera from mice which had been immunised with vaccines representative of products on the European market, in order to evaluate the performance of the coating antigen in an enzyme-linked immunosorbent assay (ELISA) which had previously performed successfully in a prevalidation study [1] and in an international validation study [2]. Results of the collaborative study indicate that the candidate batch of erysipelas ELISA coating antigen is suitable to act as a Ph. Eur. biological reference preparation. The final study report was presented at the 110th session of the Ph. Eur. Commission (June 19-21, 2001) and the material was duly adopted as Erysipelas ELISA Coating Antigen Ph. Eur. BRP No. 1 for use in the enzyme-linked immunosorbent assay in the context of the serological potency assay for inactivated erysipelas vaccines.