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- 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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Abstract
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.-
Citations
Citations to this article as recorded by
- A collaborative study to establish the second national standard for hepatitis B immunoglobulin in Korea
Chan Woong Choi, Su Kyoung Seong, Ki Won Han, Hyun Jeong Kim, Kyung Hee Sohn, Sun Bo Shim, Yun Su Bang, JungHwan Cho, In Soo Shin
Biologicals.2023; 82: 101679. CrossRef - Report on the seventh meeting of national control laboratories for vaccines and biologicals of the WHO Western Pacific and South-East Asia member states
Sun Bo Shim, Chan Woong Choi, Jin Ho Shin, Jong Won Kim, Silke Schepelmann, Jae Ho Jung, Harish Chander, Ratih Pujilestari, Madoka Kuramitsu, Masaki Ochiai, Nee Yuan Qi, Geraldine N. Dimapilis, Luu Thi Dung, Hyung Sil Moon, In Soo Shin
Biologicals.2023; 84: 101712. CrossRef
- A collaborative study to establish the second national standard for hepatitis B immunoglobulin in Korea
- 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
- 4,386 View
- 31 Download
- 5 Crossref
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Abstract
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.
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Citations
Citations to this article as recorded by- Quality analysis of BCG vaccine for bladder cancer immunotherapy using Shewhart control charts
A. A. Savina, A. A. Voropaev, A. A. Alesina
Biological Products. Prevention, Diagnosis, Treatm.2024; 24(1): 76. CrossRef - Evaluation of the viability of the Bulgarian BCG vaccine by the adenosine triphosphate assay
Elitsa Pavlova, Alexander Mihaylov, Tzvetelina Stefanova
Biotechnology & Biotechnological Equipment.2024;[Epub] CrossRef - Development of a fast and precise potency test for BCG vaccine viability using flow cytometry compared to MTT and colony-forming unit assays
Hend M. Moghawry, Mohamed E. Rashed, Kareeman Gomaa, Sameh AbdelGhani, Tarek Dishisha
Scientific Reports.2023;[Epub] CrossRef - Prospects for using flow cytometry in the quality control of live plague vaccines
N. V. Abzaeva, I. V. Kuznetsova, S. E. Gostischeva, A. M. Zhirov, D. A. Kovalev, A. V. Kostrominov, A. A. Fisun, G. F. Ivanova
Biological Products. Prevention, Diagnosis, Treatm.2023; 23(4): 560. CrossRef - Recent Developments in the Application of Flow Cytometry to Advance our Understanding of Mycobacteriumtuberculosis Physiology and Pathogenesis
Trisha Parbhoo, Samantha L. Sampson, Jacoba M. Mouton
Cytometry Part A.2020; 97(7): 683. CrossRef
- Quality analysis of BCG vaccine for bladder cancer immunotherapy using Shewhart control charts
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