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 features contributions from participants in the collaborative studies and users of the method, is focusing 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 is also explored.
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.
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Target audience
This webinar is of interest to experts from the regulatory field, national control laboratories, manufacturers, organisations promoting the 3Rs, researchers, and other interested parties.
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Duration: 3 hours, 29 minutes.
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- Session I: The BINACLE and BSP136
- Session II: Towards implementation of the BINACLE for QC testing of tetanus vaccines
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