Implementation of a Triple-Function-Analysis Method for In vitro Detection of Fully Active Tetanus Toxin to Replace In vivo Animal Models

This project will improve the BINACLE (2013) tetatnus toxicity assay, to replace animal tests. The team will add a step to the assay to measure transport into the cell cytoplasm, a critical step in tetanus toxicity.
Categories
Vaccines
Assays
Project status
100% Completed

Industry Need

Replacing historical in vivo models with in vitro testing, however animal models remain the regulatory "gold standard".

Solution

This project will initiate the development of an in vitro assay to replace the in vivo testing of a licensed tetanus vaccine component, reducing or eliminating the need for animal testing.

Outputs/Deliverables

  • Documentation for preparing tetanus toxin open structure detoxification
  • Material production information (SinBio) for translocation domain/heavy chain of tetanus toxin

Impacts

This project will initiate the development of an in vitro assay to replace the in vivo testing of a licensed tetanus vaccine component, reducing or eliminating the need for animal testing.

Publications

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Project Lead

University of Massachusetts Medical School

University of Massachusetts Medical School

Participating Organizations

New York State Department of Health (Wadsworth Center)

New York State Department of Health (Wadsworth Center)