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PHRP : Osong Public Health and Research Perspectives

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Meeting Report
The 2nd Meeting of National Control Laboratories for Vaccines and Biologicals in the Western Pacific
Hokyung Oh, Jinho Shin, Chung Keel Lee, Masaki Ochiai, Kiyoko Nojima, Chang Kweng Lim, Sanj Raut, Irene Lisovsky, Stella Williams, Ki Young Yoo, Dong-Yeop Shin, Manabu Ato, Qiang Ye, Kiwon Han, Chulhyun Lee, Naery Lee, Ji Young Hong, Kikyung Jung, Pham Van Hung, Jayoung Jeong
Osong Public Health Res Perspect. 2018;9(3):133-139.   Published online June 30, 2018
DOI: https://doi.org/10.24171/j.phrp.2018.9.3.10
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AbstractAbstract PDF

The Second Meeting of the National Control Laboratories for Vaccines and Biologicals in the Western Pacific, was jointly organized by the National Institute of Food and Drug Safety Evaluation of the Ministry of Food and Drug Safety in the Republic of Korea, and by the World Health Organization Regional Office for the Western Pacific.

In the National Lot Release Systems session countries including Canada, China, Japan, Malaysia, Vietnam, and the Republic of Korea, all shared information on their current Lot Release Systems, including current practices and developments in risk-based official lot release of vaccines.

In the session on Quality Control of Blood Products, experts from the National Institute for Biological Standards and Control shared quality control and research results for; blood coagulation factor VIII products, and the measurement of procoagulant activity in immunoglobulin products. Representatives from Japan proposed a regional collaborative study to test aggregated immunoglobulin free from complement activity. A cell-based Japanese encephalitis vaccine potency assay was proposed by representatives from Korea and they also called for voluntary participation of other National Control Laboratories in a collaborative study, on the first Korean Gloydius anti-venom standard. Participants agreed in general to continue communicating, and coordinate presentation of the study results.

Original Article
Development of a New Approach to Determine the Potency of Bacille Calmette–Guérin Vaccines Using Flow Cytometry
Eunjeong Gweon, Chanwoong Choi, Jaeok Kim, Byungkuk Kim, Hyunkyung Kang, Taejun Park, Sangja Ban, Minseok Bae, Sangjin Park, Jayoung Jeong
Osong Public Health Res Perspect. 2017;8(6):389-396.   Published online December 31, 2017
DOI: https://doi.org/10.24171/j.phrp.2017.8.6.06
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  • 20 Download
  • 1 Citations
AbstractAbstract PDF
Objectives

To circumvent the limitations of the current golden standard method, colony-forming unit (CFU) assay, for viability of Bacille Calmette–Guérin (BCG) vaccines, we developed a new method to rapidly and accurately determine the potency of BCG vaccines.

Methods

Based on flow cytometry (FACS) and fluorescein diacetate (FDA) as the most appropriate fluorescent staining reagent, 17 lots of BCG vaccines for percutaneous administration and 5 lots of BCG vaccines for intradermal administration were analyzed in this study. The percentage of viable cells measured by flow cytometry along with the total number of organisms in BCG vaccines, as determined on a cell counter, was used to quantify the number of viable cells.

Results

Pearson correlation coefficients of FACS and CFU assays for percutaneous and intradermal BCG vaccines were 0.6962 and 0.7428, respectively, indicating a high correlation. The coefficient of variation value of the FACS assay was less than 7%, which was 11 times lower than that of the CFU assay.

Conclusion

This study contributes to the evaluation of new potency test method for FACS-based determination of viable cells in BCG vaccines. Accordingly, quality control of BCG vaccines can be significantly improved.


PHRP : Osong Public Health and Research Perspectives