Alternatives in testing of bacterial toxins and antitoxins.

The potency of several novel toxin-derived biological therapeutic products now in routine medical use is determined exclusively by in vivo methods. In addition, large numbers of animals continue to be used for the potency and safety testing of therapeutic antitoxins. There is thus an increasing need to develop acceptable alternative assays for toxicity testing which would reduce the need for a mouse lethality assay in quality control. Scientific advances in the understanding of the mode of action of clostridial neurotoxins have now provided the basis for improving conventional testing procedures for both therapeutic toxins and antitoxins.