제1차 불활화 A형간염백신 국가표준품 확립

• 영문명: Establishment of the first National Reference Standard for Inactivated Hepatitis A virus vaccine
• 발행기관: 대한약학회
• 저자명: 설예원(Yewon Seol) 정지현(Jihyun Jeong) 오호경(Hokyung Oh) 이철현(Chulhyun Lee) 조건웅(Gunung Jo) 홍준호(Joonho Hong)
• 간행물 정보: 『약학회지』제69권 제5호(2025년), 505~509쪽, 전체 5쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2025.10.30

국문 초록

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.

목차

서 론(Introduction)

방 법(Methods)

결과 및 고찰(Results and Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Hepatitis A HAV Vaccine National reference standard HM175 MRC-5 ELISA