ALTEX :: Alternatives to Animal Experiments

2001, VOLUME 1

Development of in vitro Methods for the Potency Testing of Clostridial Vaccines

Erika Borrmann, Frank Schulze and Roland Diller

Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin, D-Jena

SUMMARY

Cell culture assays, using the MDCK cell line was confirmed as being sensitive to the C. perfringens epsilon toxin and VERO cell line to the C. novyi type B alpha toxin. Cell culture assays using these cells were developed and the test conditions were standardised. The antitoxin titres of rabbit antisera were calculated and compared with those of the manufacturers. The correlation coefficients between in vitro and in vivo method were calculated and were significant.

The cell culture assay offers a valid in vitro alternative to the animal experiments for the titration of sera generated in the course of potency tests of clostridial vaccines.

Keywords: 3R, cell culture assay, MDCK cell line, VERO cell line, C. perfringens epsilon toxin, C. novyi type B alpha toxin