title: [Evaluation of the relevance of the target animal safety test for the quality control of veterinary immunological medicinal products]
abstract: The legal requirements for veterinary vaccines require the testing of each new vaccine batch for safety. In the European Pharmacopoeia a target animal safety test (TAST) is regularly required as a final product test for almost all vaccine batches. This test is also required in the "General requirements for the production and control of live mammalian viral and bacterial vaccines (GRLMV)" and the "General requirements for the production and control of inactivated mammalian viral and bacterial vaccines (GRIMV)" by the European Union. In several publications the relevance of this TAST has been questioned. Particularly, it is questionable whether this animal test is able to give a significant contribution to the safety of immunologicals considering today"s standards of the quality control of animal vaccines, e.g. Good manufacturing practice and Good laboratory practice. However, due to a lack of sufficient amount of data the relevance of this animal test is discussed contradictorily. 1934 batch release protocols were sent to the Paul-Ehrlich-Institut between January of 1994 and December of 1997 for bacterial vaccines including combinations with viral antigens, vaccines against parasitic or fungal diseases and sera. During that period the manufacturers needed 5250 animals to perform the TAST. Obviously, the requirement for the TAST has a great impact on the animal numbers needed for the quality control of veterinary vaccines. The deletion of the TAST as a routine test could reduce the number of animals considerably. Preliminary results of a survey on this problem are presented and discussed.
authors.affiliation: Paul-Ehrlich-Institut, D-Langen.
authors.forename: Angela
authors.initials: A
authors.lastname: Pöbetanecker
authors.forename: Klaus
authors.initials: K
authors.lastname: Cubetaler