- Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform
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Jung Hun Ju, Naery Lee, Sun-hee Kim, Seokkee Chang, Misook Yang, Jihyun Shin, Eunjo Lee, Sunhwa Sung, Jung-Hwan Kim, Jin Tae Hong, Ho Jung Oh
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Osong Public Health Res Perspect. 2022;13(1):4-14. Published online February 8, 2022
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DOI: https://doi.org/10.24171/j.phrp.2021.0311
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 - Due to the global public health crisis caused by the coronavirus disease 2019 (COVID-19) pandemic, the importance of vaccine development has increased. In particular, a rapid supply of vaccines and prompt deployment of vaccination programs are essential to prevent and overcome the spread of COVID-19. As a part of the vaccine regulations, national lot release is regulated by the responsible authorities, and this process involves the assessment of the lot before a vaccine is marketed. A lot can be released for use when both summary protocol (SP) review and quality control testing are complete. Accelerated lot release is required to distribute COVID-19 vaccines in a timely manner. In order to expedite the process by simultaneously undertaking the verification of quality assessment and application for approval, it is necessary to prepare the test methods before marketing authorization. With the prolonged pandemic and controversies regarding the effectiveness of the COVID-19 vaccine against new variants, public interest for the development of a new vaccine are increasing. Domestic developers have raised the need to establish standard guidance on the requirements for developing COVID-19 vaccine. This paper presents considerations for quality control in the manufacturing process, test items, and SP content of viral vector vaccines.
- Evaluation of Potency on Diphtheria and Tetanus Toxoid for Adult Vaccines by In Vivo Toxin Neutralization Assay Using National Reference Standards
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Chan Woong Choi, Jae Hoon Moon, Jae Ok Kim, Si Hyung Yoo, Hyeon Guk Kim, Jung-Hwan Kim, Tae Jun Park, Sung Soon Kim
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Osong Public Health Res Perspect. 2018;9(5):278-282. Published online October 31, 2018
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DOI: https://doi.org/10.24171/j.phrp.2018.9.5.10
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Objectives
Vaccinations against diphtheria and tetanus are essential in providing immunity against these bacterial infections. The potency of diphtheria and tetanus toxoid vaccines can be measured using the in vivo toxin neutralization assay. The limit of potency of this assay was determined only for children. Therefore, we assessed the potency of adult vaccines using this assay to identify the feasibility of limit for adult vaccines.
Methods
Fifteen lots of tetanus-reduced diphtheria and tetanus-diphtheria-acellular pertussis vaccines were used. In vivo toxin neutralization and lethal challenge assays were conducted on each vaccine to calculate the potencies of the toxoids. National reference standards for toxins and antitoxins were used for in vivo toxin neutralization assay.
Results
All 15 lots satisfied the limits of potency for lethal challenge assay. The potency of diphtheria and tetanus toxoids exceeded 1 and 8 units/mL, respectively, for in vivo toxin neutralization assay.
Conclusion
Although additional studies are required for new assays and limits, the current level of potency for adult vaccines as determined by in vivo toxin neutralization assay, was demonstrated in this study. Such efforts to improve assays are expected to promote the development of diphtheria and tetanus vaccines for adults and to contribute to vaccine self-sufficiency.
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Citations
Citations to this article as recorded by  -
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
Journal of Bacteriology and Virology.2021; 51(4): 1. CrossRef
- Improved HPLC Method Using 2,3-naphthalenedicarboxaldehyde as Fluorescent Labeling Agent for Quantification of Histamine in Human Immunoglobulin Preparations
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Jung-Hwan Kim, In Soo Shin, Yoo Kyoung Lee, Ho Jung Oh, Sang Ja Ban
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Osong Public Health Res Perspect. 2011;2(2):127-134. Published online June 30, 2011
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DOI: https://doi.org/10.1016/j.phrp.2011.07.003
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2,775
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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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Citations
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Hyuk Soon Kim, Geunwoong Noh
Journal of Medical Case Reports.2023;[Epub] CrossRef - Rapid detection of histamine in fish based on the fluorescence characteristics of carbon nitride
Xiaobin Lin, Chengyi Hong, Zhengzhong Lin, Zhiyong Huang
Journal of Food Composition and Analysis.2022; 112: 104659. CrossRef - Immunotherapy using Histobulin™ in psoriasis: A case report
Hyuk Soon Kim, Geunwoong Noh
Clinical Case Reports.2022;[Epub] CrossRef - Histobulin as a complementary but essential therapeutic for Intravenous Immune Globulin Therapy of Pfeiffer‐Weber‐Christian disease with multiple allergic diseases and its effects on allergic disease: A case report
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Yasumasa Fukushima, Shunichi Aikawa
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Hyuk Soon Kim, Geunwoong Noh
Allergy, Asthma & Clinical Immunology.2021;[Epub] CrossRef - Motion sickness-relieving effects of Tamzin, a herbal formulation: In vitro and in vivo studies
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Angela Tartaglia, Marcello Locatelli, Victoria Samanidou
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