정제 브이아이 장티푸스백신 2차 국가표준품의 확립

• 영문명: Establishment of 2nd National Reference Standard for Purified Vi Polysaccharide Typhoid vaccine
• 발행기관: 대한약학회
• 저자명: 김소영(So Young Kim) 이선미(Sunmi Lee) 전솔(Sol Jeon) 양미숙(Misook Yang) 이철현(Chulhyun Lee) 정지원(Jeewon Joung) 이윤건(Youngun Lee) 박선영(Sunyoung Park) 홍진태(Jin Tae Hong) 김종원(Jong Won Kim)
• 간행물 정보: 『약학회지』제65권 제3호(2021년), 217~222쪽, 전체 6쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2021.06.30

영문 초록

This study aimed to establish a national reference standard for the purified Vi typhoid vaccine. The first national standard for the typhoid vaccine established in 2009 is currently outdated; hence, Boryung Biopharma Co. produced 4,070 vials of a candidate vaccine as per the second standard outlined in 2018.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 of the standard candidate was guaranteed through quality tests and accelerated and long-term stability tests. Reference standards ensure the accuracy and reliability of the results of quality control tests for vaccines. Thus, a collaborative study was conducted to estimate the potency of the candidate material as per the second national standard using the test methods of HPAEC-PAD (High Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection) and rocket immunoelectrophoresis. The HPAEC-PAD result was 51.5 μg/vial (95% confidence interval [CI]: 50.70-52.29 μg/vial). On the other hand, the rocket assay result was 63.4 μg/vial (95% CI: 61.08-65.89 μg/vial). In addition, the precision and proficiency of the institutes was confirmed by the CV and robust Z-score, respectively. The candidate will be registered for use as the second national standard for the purified Vi typhoid vaccine after evaluating its long-term stability. After registration, it will contribute to securing the reliability and consistency of the quality control test results for typhoid vaccines by being used in the national release system and quality control of the manufacturer.

목차

서 론(Introduction)

방 법(Methods)

결과 및 고찰(Results and Discussion)

결 론(Conclusion)

키워드

Purified Vi typhoid vaccine National Reference Standard Quality control