Alternatives to the use of animals for bacterial toxins and antitoxins.

The potency of several novel botulinum 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 and toxoid vaccines. There is thus an increasing need to develop acceptable alternative assays for toxicity testing of clostridia neurotoxins which could be applied to different toxin derived therapeutic agents, including vaccines. Scientific advances in the understanding of the mode of action of clostridial neurotoxins have now provided the basis for improving conventional testing procedures.