Supp. 1/98 - Article Summary

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Detection of extraneous virus in live vaccines

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Beate Krämer, Petra Rübmann, Karin Duchow und Klaus Cußler
Paul-Ehrlich-Institut, D-Langen
In the study in vitro alternatives to a nonvalidated and harmful animal test for the absence of extraneous virus in live vaccines were investigated.
For evaluation of a suitable in vitro method the porcine herpesvirus (Aujeszkyvirus, Pseudorabiesvirus) was used as a model virus. In artificially contaminated live vaccines the aujeszkyvirus could be detected by moleculargenetical and cellular methods. Regarding the threshold values of virus detection in vitro tests showed to be more efficacious than animal testing.
Meanwhile the European Pharmacopoeia Commission deleted the animal test for extraneous virus from two monographs. The discussion, if respective animal testing can be cancelled for the other live vaccines as well, is still ongoing.
The study was supported by the German Ministry of Education, Science, Research and Technology.

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