[Abnormal toxicity - a relevant safety test under GLP- and GMP-conditions in the production of vaccines?]

ABSTRACT

The German Pharmacopoeia requires a test for abnormal toxicity in mice and guinea pigs as an unspecific safety test for vaccines and sera. This paper deals with the relevance of abnormal toxicity after the introduction of GMP- and GLP-conditions in the production of veterinary biologicals. Preliminary results: 1.The evidence of the test on abnormal toxicity as a prediction for (harmful) batches is insufficient, because a) the specificity is missing b) misinterpretations of reactions caused by compounds in mice and guinea pigs are possible which are independent of the innocuity of the medical products for the target animal. 2.The concentration of adjuvants and preservatives frequently leads to local and/or generalized symptoms of incompatibility with minor relevance to the target species. 3.The large number of animals used for this test and the suffering during the procedure is not justified in view of the negligible increase of safety of the product. Therefore the test for abnormal toxicity should be removed from the Pharmacopoeia.