Standardization of the first Korean national reference standard for snake ( Gloydius brevicaudus ) antivenom
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Toxicol Res. https://doi.org/10.1007/s43188-020-00047-0
Toxicological Research
ORIGINAL ARTICLE
Standardization of the first Korean national reference standard for snake (Gloydius brevicaudus) antivenom Kiwon Han1 · Hojin Song1,2 · Chan Woong Choi1 · Sangmi Park1 · Yong Seok Kang1 · Kikyung Jung1 · Byung‑Hwa Lee3 · Yoshimasa Takahashi4 · Takayuki Matsumura4 · Akihiko Yamamoto5 · Yang Jin Kim6 · Seung‑wan Jee7 · Jaeok Kim1 Received: 21 January 2020 / Revised: 26 February 2020 / Accepted: 26 March 2020 © Korean Society of Toxicology 2020
Abstract In 2017, the second national reference standard (NRS) for Gloydius snake venom was established to replace the first NRS for Gloydius snake venom. In connection with the second venom NRS, a candidate for the first NRS for Gloydius snake antivenom was produced in 2017. In this study, the qualification of the candidate was estimated and the potency was determined by a collaborative study. The potency (anti-lethal titer and anti-hemorrhagic titer) of the candidate was determined by measuring the capability of the antivenom to neutralize the lethal and hemorrhagic effects of the second NRS for Gloydius snake venom, which was calibrated against the regional reference standard for Gloydius snake antivenom established in 2006. Two Korean facilities contributed data from 20 independent assays. Subsequently, one foreign national control research laboratories participated in this collaborative study. The general common potency of the anti-lethal and anti-hemorrhagic titers was obtained from the results of a total of 25 tests performed at three facilities. According to the results of the present study, the candidate preparation showed good quality and is judged to be suitable to serve as the first NRS for Gloydius snake antivenom with the following potency: an anti-lethal titer of 3100 unit (U) (95% confidence interval 2991–3276 U) and anti-hemorrhagic titer of 3000 U (95% confidence interval 2849–3159 U). In conclusion, the first NRS for Gloydius snake antivenom was established in this study. This reference standard will be used routinely for quality control of a snake antivenom product by manufacturer in Korea, which also can be used for national quality control, including a national lotrelease test of the snake antivenom product. Keywords National reference standard · Collaborative study · Gloydius snake antivenom · Anti-lethal titer · Antihemorrhagic titer
Kiwon Han and Hojin Song contributed equally to this work. * Jaeok Kim [email protected] 1
Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Osong Health Technology Administration Complex 187, Osongsaengmyeong‑2‑ro, Heungdeok‑gu, Cheongju 28159, Korea
2
Department of Manufacturing Pharmacy, Chungbuk National University College of Pharmacy, Cheongju, Korea
3
Quality Control Team, Korea Vaccine Co., Ltd., Suwon, Korea
4
Department of Immunology, National Institute of Infectious Diseases, Tokyo, Japan
5
Division of Biosafety Control and Research
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