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Article

Practical Application of Novel Test Methods to Evaluate the Potency of Botulinum Toxin: A Comparison Analysis among Widely Used Products in Korea

1
Department of Dermatology, Chungnam National University Sejong Hospital, Sejong 30099, Korea
2
NABOTA Research and Development Team, Daewoong Pharmaceuticals, Seoul 06973, Korea
3
Department of Dermatology, College of Medicine, Chung-Ang University, Seoul 06973, Korea
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Toxins 2021, 13(12), 833; https://doi.org/10.3390/toxins13120833
Received: 15 October 2021 / Revised: 18 November 2021 / Accepted: 22 November 2021 / Published: 23 November 2021
(This article belongs to the Special Issue Botulinum Toxins in Clinical Practice)
The safe and effective dosing of botulinum neurotoxins (BoNTs) requires accurate and reliable methods to measure their potency. Several novel methods have been introduced over the past decade; however, only few studies have compared the potency of BoNT products with that of the LD50 and other alternative assays. Therefore, the objective of this study was to comparatively evaluate widely used BoNT products using various test methods. Four types of BoNTs (prabotulinumtoxin A, onabotulinumtoxin A, neubotulinumtoxin A, and letibotulinumtoxin A) were used in this study. The estimated potency was assessed using the LD50 assay, and the total BoNT type A protein levels were measured using the enzyme-linked immunosorbent assay (ELISA). The in vitro efficacy of the BoNTs was determined using fluorescence resonance energy transfer (FRET) and surface plasmon resonance (SPR) assays. The results showed differences in the total amount of BoNT protein and the cleavage activity of SNAP-25 within all types of BoNTs. The SPR study seemed to be useful for evaluating the potency by specifically measuring intact 19S neurotoxin, and these results provide new insights for assessing different BoNT products. View Full-Text
Keywords: botulinum toxin; potency; LD50; endopeptidase; rapid detection botulinum toxin; potency; LD50; endopeptidase; rapid detection
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MDPI and ACS Style

Hong, J.-Y.; Kim, J.-H.; Jin, J.-E.; Shin, S.-H.; Park, K.-Y. Practical Application of Novel Test Methods to Evaluate the Potency of Botulinum Toxin: A Comparison Analysis among Widely Used Products in Korea. Toxins 2021, 13, 833. https://doi.org/10.3390/toxins13120833

AMA Style

Hong J-Y, Kim J-H, Jin J-E, Shin S-H, Park K-Y. Practical Application of Novel Test Methods to Evaluate the Potency of Botulinum Toxin: A Comparison Analysis among Widely Used Products in Korea. Toxins. 2021; 13(12):833. https://doi.org/10.3390/toxins13120833

Chicago/Turabian Style

Hong, Ji-Yeon, Jong-Hee Kim, Jung-Eun Jin, Sun-Hye Shin, and Kui-Young Park. 2021. "Practical Application of Novel Test Methods to Evaluate the Potency of Botulinum Toxin: A Comparison Analysis among Widely Used Products in Korea" Toxins 13, no. 12: 833. https://doi.org/10.3390/toxins13120833

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