The testing procedure in the European Pharmacopoeia (Ph. Eur.) for demonstrating the absence of tetanus toxin from toxoids used in the manufacture of both human and veterinary vaccines currently consists of an in vivo test in guinea pigs.

In accordance with the 3Rs policy of the EDQM, project BSP136 of the Biological Standardisation Programme evaluated the applicability of the in vitro BINding And CLEavage (BINACLE) method as a novel alternative to the in vivo test.

This webinar, which will feature contributions from participants in the collaborative studies and users of the method, will focus on the method’s scientific background and the outcomes of the collaborative studies organised by the EDQM with the scientific support of the Paul-Ehrlich-Institut (Germany). The potential impact of this project on the Ph. Eur. monographs related to tetanus vaccines for human and veterinary use will also be explored.

The webinar will include live Q&A sessions.

Download the programme

Don’t hesitate to also consult the publications  “Collaborative study for the characterisation of the BINACLE Assay for in vitro detection of tetanus toxicity in toxoids” – Part 1 and Part 2.

REGISTER NOW

This webinar is open to experts from the regulatory field, national control laboratories, manufacturers, organisations promoting the 3Rs, researchers, and other interested parties.

Participation is free of charge.