DCVMN 3Rs Workshop: Implementing the Diphtheria-Tetanus Single Dilution Assay for Potency Calculation

DCVMN 3Rs Workshop Implementing the Diphtheria-Tetanus Single Dilution Assay for Potency Calculation January 27th, 2022 12:00 – 14:45 CET See attached agenda. Registration link: https://zoom.us/webinar/register/WN_8-2RM5XnRC-sCoSIft2RqQ Workshop summary The single dilution assay for the potency calculation of Diphtheria-Tetanus containing vaccines reduce the number of animals required for the serological potency assay. An amendment to the diphtheria and tetanus sections of wP containing vaccines concerning single dilution and in vitro potency assays was adopted by the Expert Committee on Biological Standardization in 2004 (c.f. Requirements for Diphtheria, tetanus, pertussis and combined vaccines. In: WHO Expert Committee on Biological Standardization. Fortieth report. Geneva, World Health Organization, 1990, Annex 2 – WHO Technical Report Series, No. 800) and the single dilution is included into the Tetanus and Diphtheria TRS 980. The objectives of the workshop are: A) Introduce the opportunity for the implementation of the single dilution assay for DT-containing vaccines, via the experience of DCVMN members B) Discuss about a DCVMN dedicated project to support the implementation among the network DCVMN welcome you and any representative from your company that has Quality and Regulatory Affairs expertise or is interested in the topic.

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