제1차 불활화 A형간염백신 국가표준품 확립

Establishment of the first National Reference Standard for Inactivated Hepatitis A virus vaccine

This study aimed to establish the first national reference standard for inactivated Hepatitis A virus vaccine used for potency assays. The candidate material was manufactured using Hepatitis A virus antigen (HM175 strain) and MRC-5 (Medical Research Council) cell strain cell line, in accordance with established HAV vaccine manufacturing process approved as Good Manufacturing Practice. The frozen-liquid candidate preparation was tested for physicochemical and biological properties, including sterility test, formaldehyde test, endotoxin test, inactivated test, and potency test. Long-term and accelerated stability tests were conducted to evaluate the validity of the candidate preparation. For determination of assigned potency in IU, a collaborative study was carried out involving three institutions, including the vaccine manufacturer and testing laboratories. The potency was A quantitative assay using ELISA for HAV antigen was performed, and the results were statistically analyzed. The overall mean potency estimate for candidate was 23.8 IU/mL, with a coefficient of variation of 4.56% and a standard deviation of 0.1, demonstrating consistency of results within the institutions it was deemed suitable to serve as the Korean national reference standard for inactivated Hepatitis A virus vaccine.