A Collaborative Study to Establish the Second Korean National Reference Standard for Snake Venom

Area of Science:

• Toxicology
• Pharmacology
• Biotechnology

Background:

• The first national reference standard (NRS) for Gloydius snake venom, established in 2015, required replacement.
• A candidate for the second NRS was produced to maintain consistent quality control for antivenom production.

Purpose of the Study:

• To determine the potency of the candidate for the second national reference standard (NRS) of Gloydius snake venom.
• To estimate the qualification and suitability of the candidate for use as the Korean NRS.

Main Methods:

• Collaborative study involving three Korean facilities and two foreign laboratories.
• Determination of murine lethal titers and lapine hemorrhagic titers against a regional working reference standard (RWRS).
• Statistical analysis using the Reed-Muench method for lethality and a mixed-effects model for hemorrhage.

Main Results:

• Potency results expressed as lethal titer: 90.13 μg/TD (95% CI: 87.39–92.86 μg) and hemorrhagic titer: 10.80 μg/TD (95% CI: 10.46–11.14 μg).
• The candidate preparation demonstrated good quality, meeting the criteria for a national reference standard.
• The candidate is suitable for use as the Korean NRS for Gloydius snake venom.

Conclusions:

• The second national reference standard (NRS) for Gloydius snake venom has been successfully established.
• This new NRS will be utilized for national quality control and lot release testing of Korean antivenom products.
• Ensures reliable and consistent quality of antivenom against Gloydius snakebites in Korea.