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Development of an Innovative in Vitro Potency Assay for Anti-Botulinum Antitoxins.


ABSTRACT: Botulinum neurotoxins are bacterial proteins that cause botulism, a life-threatening disease. Therapy relies mostly on post-intoxication antibody treatment. The only accepted method to measure the potency of, and to approve, antitoxin preparations is the mouse lethality neutralization bioassay. However, this assay is time-consuming, labor-intensive, costly, and raises ethical issues related to the large numbers of laboratory animals needed. Until now, all efforts to develop an alternative in vitro assay have not provided a valid replacement to the mouse potency assay. In the present study, we report the development of an innovative in vitro assay for determining botulinum antitoxin potency, using botulinum type B as a model. The concept of the assay is to mimic two fundamental steps in bot

SUBMITTER: Rosen O 

PROVIDER: S-EPMC5086636 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature