Bioassays for evaluation of medical products derived from bacterial toxins

Bioassays play central role in evaluation of biological products and those derived from bacterial toxins often rely exclusively on in vivo models for assurance of safety and potency. This chapter reviews existing regulatory approved methods designed to provide information on potency and safety of complex biological medicines with an insight into strategies considered for alternative procedures.

► Bioassays for potency and safety are largely dependent on animals. ► Review updates reader on new alternative bioassays considered for potency and safety of products derived from toxins. ► Protection models by toxin challenge can be replaced by serological correlates provided that toxin neutralization is established. ► In vitro assays for toxins take into account enzyme activity and receptor binding properties. ► Cell-based assays are in development for several toxins with stem cells considered as highly promising model for neurotoxins.