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KMID : 0370220210650030217
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Yakhak Hoeji
2021 Volume.65 No. 3 p.217 ~ p.222
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Establishment of 2nd National Reference Standard for Purified Vi Polysaccharide Typhoid vaccine
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Kim So-Young
Lee Sun-Mi
Jeon Sol
Yang Mi-Sook
Lee Chul-Hyun
Joung Jee-Won
Lee Youn-Gun
Park Sun-Young
Hong Jin-Tae
Kim Jong-Won
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Abstract
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This study aimed to establish a national reference standard for the purified Vi typhoid vaccine. The firstnational standard for the typhoid vaccine established in 2009 is currently outdated; hence, Boryung Biopharma Co.
produced 4,070 vials of a candidate vaccine as per the second standard outlined in 2018. The large-scale manufacture ofthe standard candidate was guaranteed through quality tests and accelerated and long-term stability tests. Referencestandards ensure the accuracy and reliability of the results of quality control tests for vaccines. Thus, a collaborative studywas conducted to estimate the potency of the candidate material as per the second national standard using the test methodsof HPAEC-PAD (High Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection) and rocketimmunoelectrophoresis. The HPAEC-PAD result was 51.5 μg/vial (95% confidence interval [CI]: 50.70-52.29 μg/vial). Onthe other hand, the rocket assay result was 63.4 μg/vial (95% CI: 61.08-65.89 μg/vial). In addition, the precision andproficiency of the institutes was confirmed by the CV and robust Z-score, respectively. The candidate will be registeredfor use as the second national standard for the purified Vi typhoid vaccine after evaluating its long-term stability. Afterregistration, it will contribute to securing the reliability and consistency of the quality control test results for typhoidvaccines by being used in the national release system and quality control of the manufacturer.
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KEYWORD
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Purified Vi typhoid vaccine, National Reference Standard, Quality control
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