Osong Public Health and Research Perspectives

Meeting Report

The 2^nd 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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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

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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

Original Article

Improved HPLC Method Using 2,3-naphthalenedicarboxaldehyde as Fluorescent Labeling Agent for Quantification of Histamine in Human Immunoglobulin Preparations: Jung-Hwan Kim, In Soo Shin, Yoo Kyoung Lee, Ho Jung Oh, Sang Ja Ban; Osong Public Health Res Perspect. 2011;2(2):127-134. Published online June 30, 2011; DOI: https://doi.org/10.1016/j.phrp.2011.07.003

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Abstract PDF

Objectives
To develop and optimize quantitative HPLC method using 2,3-naphthalenedicarboxaldehyde (NDA) after simple and efficient solid phase extraction to determine the histamine in a biopharmaceutical (Histobulin™).
Methods
The HPLC method was established using NDA-induced Histobulin and compared with the recently reported HPLC method using o-phthaldehyde (OPA). The validated NDA-applied HPLC method was adjusted to 15 lots of Histobulin and compared by the current lot-release-test method using fluorimetry in recovery of histamine and reproducibility.
Results
Analyses of six HPLC chromatograms using NDA and OPA each were compared. NDA produced a more stable chromatogram baseline than OPA, and showed better stability. The HPLC analysis was validated in accuracy (91–103%), precision (interday/intraday assay CV ≤2.30%), and linearity of dose–response curve (R² ≥ 0.9919). The detection limit was 0.0076 μg/mL and the quantitative limit was 0.0229 μg/mL. The amount of histamine per 12 mg of immunoglobulin was determined to be 0.17 ± 0.016 μg by the HPLC and 0.025 ± 0.013 μg by the current lot-release-test method using fluorimetry.
Conclusion
NDA derivatization showed better stability compared with the OPA method. Therefore the newly established NDA-derivatizated HPLC method may be more suitable than the fluorimetric method in lot-release-tests of biopharmaceuticals.

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Journal of AOAC INTERNATIONAL.2020; 103(5): 1223. CrossRef
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Chromatographia.2013; 76(21-22): 1365. CrossRef

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