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Toxins 2016, 8(10), 276; doi:10.3390/toxins8100276

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

Department of Biotechnology, Israel Institute for Biological Research, Ness Ziona 7410001, Israel
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Academic Editors: Jianlong Lou and James D. Marks
Received: 8 August 2016 / Revised: 14 September 2016 / Accepted: 19 September 2016 / Published: 24 September 2016
(This article belongs to the Special Issue Botulinum Neurotoxins Antibody and Vaccine)
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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 botulinum intoxication: receptor binding and catalytic activity. By simulating these steps in vitro we were able to accurately determine the potency of antitoxin preparations. The reproducibility of the assay was high with a CV < 13%. Most importantly, the antitoxin potency measured by the in vitro assay highly correlated with that measured by the standard in vivo mouse assay (r = 0.9842, p < 0.0001). Thus, this new in vitro assay has the potential to be considered, after validation, as a replacement to the mouse assay for quantitating neutralizing antibody concentrations in pharmaceutical botulinum antitoxin preparations. Future adoption of this in vitro assay would minimize the use of laboratory animals, speed up the time, and reduce the cost of botulinum antitoxin approval. View Full-Text
Keywords: botulinum; anti-botulinum antibodies; potency; in vitro assay botulinum; anti-botulinum antibodies; potency; in vitro assay
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MDPI and ACS Style

Rosen, O.; Ozeri, E.; Barnea, A.; David, A.B.; Zichel, R. Development of an Innovative in Vitro Potency Assay for Anti-Botulinum Antitoxins. Toxins 2016, 8, 276.

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