Replacing historical in vivo models with in vitro testing, however animal models remain the regulatory "gold standard".
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.
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.
By implementing a triple‑function in‑vitro tetanus toxin assay that adds direct measurement of the translocation domain (using newly identified anti‑translocation MAbs) alongside established binding and L‑chain protease activity, an organization will reduce reliance on in‑vivo animal testing and its associated costs, shorten method development and lot‑release timelines through higher‑throughput, lab‑based analytics, and enable a more mechanistic, correlation‑rich potency determination—improving batch consistency and regulatory confidence without compromising product quality or compliance.
Documentation for preparing tetanus toxin open structure detoxification Material production information (SinBio) for translocation domain/heavy chain of tetanus toxin
Cannon, R. D. & Cohane, K., Implementation of a Triple-Function-Analysis Method for In vitro Detections of Fully Active Tetanus Toxin to Replace In vivo Animal Models, NIIMBL National Meeting, Washington, DC, July 14, 2021.
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University of Massachusetts Medical School
New York State Department of Health (Wadsworth Center)
