Collaborative Study for the Establishment of Erysipelas ELISA Coating Antigen European Biological Reference Preparation Batch N°1 Project leader: K. Cussler, PEI
نویسندگان
چکیده
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 EDQM3, 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 N°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.
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