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Review Article
Points to consider for COVID-19 vaccine quality control and national lot release in Republic of Korea: focus on a viral vector platform
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
Osong Public Health Res Perspect. 2022;13(1):4-14.   Published online February 8, 2022
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  • 175 Download
Graphical AbstractGraphical Abstract AbstractAbstract PDF
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.
Corrigendum to “Evaluation of Potency on Diphtheria and Tetanus Toxoid for Adult Vaccines by In Vivo Toxin Neutralization Assay Using National Reference Standards”[Osong Public Health Res Perspect 2018;9(5):278–82]
Chan Woong Choi, Jae Hoon Moon, Jae Ok Kim, Si Hyung Yoo, Hyeon Guk Kim, Jung-Hwan Kim, Tae Jun Park, Sung Soon Kim
Osong Public Health Res Perspect. 2018;9(6):363-363.   Published online December 31, 2018
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  • 32 Download
Brief Report
Evaluation of Potency on Diphtheria and Tetanus Toxoid for Adult Vaccines by In Vivo Toxin Neutralization Assay Using National Reference Standards
Chan Woong Choi, Jae Hoon Moon, Jae Ok Kim, Si Hyung Yoo, Hyeon Guk Kim, Jung-Hwan Kim, Tae Jun Park, Sung Soon Kim
Osong Public Health Res Perspect. 2018;9(5):278-282.   Published online October 31, 2018
  • 5,258 View
  • 56 Download
  • 2 Crossref
AbstractAbstract PDF

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.


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.


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.


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.


Citations to this article as recorded by  
  • Discovery and development of COVID‐19 vaccine from laboratory to clinic
    Venkatesan Saravanan, Bharath Kumar Chagaleti, Pavithra Lakshmi Narayanan, Vijay Babu Anandan, Haritha Manoharan, G.V. Anjana, Ramalingam Peraman, S. Karthik Raja Namasivayam, M. Kavisri, Jesu Arockiaraj, Kathiravan Muthu Kumaradoss, Meivelu Moovendhan
    Chemical Biology & Drug Design.2024;[Epub]     CrossRef
  • 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
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
  • 3,647 View
  • 17 Download
  • 19 Crossref
AbstractAbstract PDF
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™).
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.
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.
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.


Citations to this article as recorded by  
  • DNAzyme-based and smartphone-assisted colorimetric biosensor for ultrasensitive and highly selective detection of histamine in meats
    Junjun Wang, Yue Tang, Jia Zheng, Zhengmin Xie, Jianli Zhou, Yuangen Wu
    Food Chemistry.2024; 435: 137526.     CrossRef
  • Solid-State synthesis of transition nanometal oxides (MnO2, Co3O4, NiO, and ZnO) for catalytic and electrochemical applications
    Prabha Devi Balakrishnan, Chinnathambi Sekar, Rajendran Ramesh, Thathan Premkumar, Ponnusamy Kanchana
    Journal of Industrial and Engineering Chemistry.2024;[Epub]     CrossRef
  • Effects of the immunoglobulin/histamine complex on panic disorder concurrent with chronic spontaneous urticaria: a case report
    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
    Geunwoong Noh
    Clinical Case Reports.2021; 9(2): 966.     CrossRef
  • Immunotherapy using Histobulin in atopic dermatitis
    Geunwoong Noh
    Clinical Case Reports.2021; 9(1): 113.     CrossRef
  • Colorimetric sensing of histamine in aqueous solution by a system composed of alizarin complexone and Ni2+ complex via indicator displacement approach
    Yasumasa Fukushima, Shunichi Aikawa
    Tetrahedron Letters.2021; 72: 153088.     CrossRef
  • Induction of remission in chronic urticaria by immunotherapy using immunoglobulin/histamine complex (Histobulin™): a case report
    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
    N. Ilaiyaraja, Dongzagin Singsit, Mahantesh M Patil, S. Priyadharshini, V. Rashmi, Farhath Khanum
    Food Bioscience.2020; 35: 100595.     CrossRef
  • Trends in the Analysis of Biopharmaceuticals by HPLC
    Angela Tartaglia, Marcello Locatelli, Victoria Samanidou
    Current Analytical Chemistry.2020; 16(1): 52.     CrossRef
  • Validation of HPLC Method for Determination of Histamine in Human Immunoglobulin Formulations
    Michikazu Tanio, Toru Nakamura, Hideki Kusunoki, Kyohei Ideguchi, Kazuyuki Nakashima, Isao Hamaguchi
    Journal of AOAC INTERNATIONAL.2020; 103(5): 1223.     CrossRef
  • 4-Methoxy-ortho-phthalaldehyde: a promising derivatizing agent for the fluorimetric evaluation of histamine in seafood
    Clémence Moitessier, Khémesse Kital, Pierre-Edouard Danjou, Francine Cazier-Dennin
    Talanta Open.2020; 2: 100014.     CrossRef
  • A novel biomimetic immunoassay method based on Pt nanozyme and molecularly imprinted polymer for the detection of histamine in foods
    Xiaofeng Wang, Xiaoqing Song, Lin Si, Longhua Xu, Zhixiang Xu
    Food and Agricultural Immunology.2020; 31(1): 1036.     CrossRef
  • Development of a Rapid and Eco-Friendly UHPLC Analytical Method for the Detection of Histamine in Fish Products
    Antonello Cicero, Francesco Giuseppe Galluzzo, Gaetano Cammilleri, Andrea Pulvirenti, Giuseppe Giangrosso, Andrea Macaluso, Antonio Vella, Vincenzo Ferrantelli
    International Journal of Environmental Research an.2020; 17(20): 7453.     CrossRef
  • Silver nanoparticles decorated graphene nanoribbon modified pyrolytic graphite sensor for determination of histamine
    Neeraj Kumar, Rajendra N. Goyal
    Sensors and Actuators B: Chemical.2018; 268: 383.     CrossRef
  • Amperometric Biosensor Based on Diamine Oxidase/Platinum Nanoparticles/Graphene/Chitosan Modified Screen-Printed Carbon Electrode for Histamine Detection
    Irina Apetrei, Constantin Apetrei
    Sensors.2016; 16(4): 422.     CrossRef
  • Comparison of Methods for Measuring Histamine by ELISA and HPLC-MS Assay In Vitro
    In Hee Lee, Yoo Hyun Kim
    Korean Journal of Clinical Laboratory Science.2015; 47(4): 306.     CrossRef
  • UPLC versus HPLC on Drug Analysis: Advantageous, Applications and Their Validation Parameters
    Mehmet Gumustas, Sevinc Kurbanoglu, Bengi Uslu, Sibel A. Ozkan
    Chromatographia.2013; 76(21-22): 1365.     CrossRef

PHRP : Osong Public Health and Research Perspectives