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EDQM Strasbourg, France 30/05/2024
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Save the date – Get ready to join our webinar on 12 November 2024

BINACLE Assay for Tetanus Neurotoxin: Outcomes of Collaborative Study BSP136

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 line with the 3Rs policy of the Ph. Eur., 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. The study was successfully concluded, and its outcomes and implications will be discussed in an upcoming webinar.

We look forward to seeing you on 12 November 2024!

More information on the webinar, including registration and a draft programme, will be published soon.

For any queries, please contact the EDQM via our HelpDesk.