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Establishment of the 2nd National Reference Standard for Diphtheria toxin in Korea

Journal of Bacteriology and Virology 2021년 51권 1호 p.1 ~ 8
김소영, 이진웅, 전솔, 안수정, 황인영, 문재훈, 박종관, 양태승, 손재운, 김대근, 장정원, 박슬기, 최은아, 김진규, 홍진태, 김종원,
소속 상세정보
김소영 ( Kim So-Young ) - Ministry of Food and Drug Safety National Institute of Food and Drug Safety Evaluation
이진웅 ( Lee Jin-Woong ) - Ministry of Food and Drug Safety National Institute of Food and Drug Safety Evaluation
전솔 ( Jeon Sol ) - Ministry of Food and Drug Safety National Institute of Food and Drug Safety Evaluation
안수정 ( An Su-Jung ) - Ministry of Food and Drug Safety National Institute of Food and Drug Safety Evaluation
황인영 ( Hwang In-Yeong ) - Ministry of Food and Drug Safety National Institute of Food and Drug Safety Evaluation
문재훈 ( Moon Jae-Hoon ) - GC Pharma
박종관 ( Park Jong-Kwan ) - GC Pharma
양태승 ( Yang Tae-Seung ) - GC Pharma
손재운 ( Son Jae-Woon ) - GC Pharma
김대근 ( Kim Dae-Geun ) - GC Pharma
장정원 ( Jang Jeong-Won ) - GC Pharma
박슬기 ( Park Seul-Gi ) - GC Pharma
최은아 ( Choi Eun-Ah ) - GC Pharma
김진규 ( Kim Jin-Kyu ) - GC Pharma
홍진태 ( Hong Jin-Tae ) - Chungbuk National University College of Pharmacy
김종원 ( Kim Jong-Won ) - Ministry of Food and Drug Safety National Institute of Food and Drug Safety Evaluation

Abstract


The reference standards perform an important role in standardization and consistent quality control of biologicals such as vaccines. The study was aimed to establish the 2nd national standard for diphtheria toxin used in diphtheria potency assay of diphtheria toxoid combined vaccines. The stocks of the first national standard established in 2007 were exhausted, and in 2019, Freeze-dried diphtheria toxin was produced in two lots, 1,962 and 1,942 vials respectively. The feasibility of manufacturing was evaluated through quality evaluation and long-term and accelerated stability tests for candidates. In order to assign the potency of candidate standards, the collaborative study was conducted with five institutions including vaccine manufacturers. The potency of the candidate standards was assigned a value of 210 L+/vial (95% confidence interval- MFDSB- 19-002: 208.52~221.58 L+/vial, MFDS-B-19-003: 208.63~219.61 L+/vial). It was confirmed that there was a significant difference in the basic statistics of institutions through One-way ANOVA. But when the post hoc test was conducted to verify the result of ANOVA, not much difference was shown from individual institutions as low variability. Additionally, statistical equivalence was confirmed from institutions. The candidate standard whose quality has been verified will be registered as the second national standard for diphtheria toxin.

키워드

Bacterial vaccine; Diphtheria toxoid combined vaccine; Diphtheria toxin; National Reference Standard; Potency assay; Quality control

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