Padronização de um teste de potência de toxóide de Clostridium septicum em linhagem contínua de célula

Abstract

Clostridium septicum is the pathogen that causes the malignat edema. Because of its strong cytotoxic alpha toxin, infections are often lethal. To prevent losses in animal, vaccination with alpha toxóide vaccines is carried out. The potency test of the vaccines have to be done byneutralization test in mice or intradermally into guinea-pig skin. An alternative method to detect neutralizing antibodies based on the use of cell cultures was standardized. Cell culture titrations of C. septicum alpha toxin performed on rabbit at the levels of test prescribed by BritishPharmacopeia have produced consistent results which agree closely with animal models. Cell culture indicators are more sensitive than in vivo methods, permitting detection of substantially lower titers than possible in vivo indicators. It concluded that cell culture titration offers a valid invitro alternative to the use mouse lethal and guinea-pig dermonecrotic indicators for the titration of sera of potency test of C. septicum alpha toxin vaccines