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

So Young Kim; Jinwoong Lee; Sol Jeon; Su Jung An; In yeong Hwang; Jae Hoon Moon; Jong Kwan Park; Taeseung Yang; Jaewoon Son; Daegeun Kim; Jeongwon Jang; Seulgi Park; Eun Ah Choi; Jin Kyu Kim; Jin Tae Hong; Jong Won Kim

doi:10.4167/jbv.2021.51.1.001

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2021 Vol.51, Issue 1 Next Page

Original Article

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

31 March 2021. pp. 1-8

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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- MFDS- B-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.

Keywords

Bacterial vaccine

Diphtheria toxoid combined vaccine

Diphtheria toxin

National Reference Standard

Potency assay

Quality control

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Information

Publisher :The Korean Society for Microbiology and The Korean Society of Virology
Publisher(Ko) :대한미생물학회‧대한바이러스학회
Journal Title :JOURNAL OF BACTERIOLOGY AND VIROLOGY
Volume : 51
No :1
Pages :1-8
Received Date : 2021-01-11
Revised Date : 2021-03-22
Accepted Date : 2021-03-26
DOI :https://doi.org/10.4167/jbv.2021.51.1.001

JOURNAL OF BACTERIOLOGY AND VIROLOGY ISSN:1598-2467(Print) 2093-0429(Online)

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