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Updated: May 16, 2025

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
Published on: May 11, 2020
Changes in regulatory requirements for potency testing of snake antivenom in Korea
Wonjong Lee1, Hyun Jeong Kim1, Yu Jeong Oh1
1Biopharmaceuticals & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea.
Abstract:
Snake antivenoms are manufactured under Good Manufacturing Practice, with quality controlled according to Korean regulations. Potency results for anti-lethal and anti-hemorrhagic titers collected since 2017 showed ranges of 6280-15,120 and 6080-10,160 U/vial, respectively. A strong correlation (r = 0.8356-0.9216) was observed between the two tests. These findings support the removal of the anti-hemorrhagic test from Korean regulations, aligning with global efforts to reduce animal testing while ensuring the efficacy of biological products.
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