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National Institute of Health Korea Vaccine Resarch Center

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Vaccine Center of Assisting Safety & Technology(K-VCAST) (An institution dedicated to technical support for vaccine commercialization)
Institution overview
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기관개요
Institution type Non-profit organization (incorporated foundation) under the Ministry of Food and Drug Safety(MFDS)
Basis for establishment Article 90-2 of the Pharmaceutical Affairs Act (Establishment of Vaccine Center of Assisting Safety & Technology) Purpose of establishment Dedicated to securing vaccine quality and technical support for commercialization
Business areas Testing and inspection institutions, academic/research services, regulatory science training projects, etc.
Director Baek, Seon Young Website www.k-vcast.kr
Establishment date Aug. 26, 2020 Location 102-1, Sandan-gil, Hwasun-eup, Hwasun-gun, Jeollanam-do, Korea.
Main tasks
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Quality testing to confirm the safety and effectiveness of vaccines (From raw and subsidiary materials to finished products)
  • Vaccine quality testing

    - Quality testing of national preventive vaccines for legal communicable diseases

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    Quality testing of national preventive vaccines for legal communicable diseases
    Infectious diseases Vaccine Test items Test method
    Pediatric enteritis Rota
    (Rotavirus vaccine)    		 Virus content heat stability qPCR, CCID50
    human papilloma virus infection HPV
    (Human papillomavirus vaccine)    		 Confirmation and content ELISA
    Hepatitis A HepA
    (Hepatitis A vaccine)    		 Animal antibody titer measurement antigen content Animal testing, ELISA
    Shingles HZV
    (Herpes zoster vaccine)    		 Virus content, confirmation Cell culture
    Tetanus/Diphtheria/Pertussis TdaP/Td
    (Tetanus･Diphtheria･Pertussis vaccine)    		 Diphtheria and tetanus detoxification, acellular pertussis detoxification, confirmation and assay Animal testing, ELISA, ELISA
    Pneumococcus PCV13
    (Pneumococcal conjugate vaccine)    		 Confirmation and content confirmation Slot-blot Nephelometry
    Measles/Mumps/Rubella MMR
    (Measles･Mumps･Rubella vaccine)    		 Virus content, confirmation CCID50

    - General testing of biological products such as vaccines (physico-chemistry and microbiology fields)

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    General testing of biological products such as vaccines (physico-chemistry and microbiology fields)
    Actual dose of injection Insoluble fine particles pH measurement 2-Phenoxyethanol
    (preservative)    		 Formaldehyde
    (deactivator)
    Quantification of aluminum
    (immune enhancer)    		 Protein quantification
    (Lowry, BCA)    		 Humidity
    (Karl Fisher)    		 Sterility test
    (membrane filter)    		 Endotoxin
    (gel-clot, chromogenic)
Analysis of specimens for clinical trials to support domestic clinical trials
  • The 「specimen analysis agencies for clinical trials」 designated by the MFDS (May 8, 2023)

    - Analysis of immunogenicity for HPV, HAV, TdaP, PCV, HFM, etc.

  • Analysis of humoral and cellular immunogenicity of vaccines and biopharmaceuticals

    - ELISA, PBNA, ELISpot, SBA, PRNT, FRNT, etc.

    Test request

    Consultation and quote

    Completion of a request form

    Request acceptance

    Analysis

    Report issuance

  • Vaccine immunogenicity assay
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Vaccine immunogenicity assay
Binding antibody analysis ELISA
(Enzyme-linked immunosorbent assay)		 • Quantification of antigen protein
• Evaluation of active antibody titer
• Vaccines for HAV, HPV, TdaP, HFM, and typhoid fever
Neutralizing antibody analysis PRNT
(Plaque reduction neutralization test)		 • Quantification of the area where cytopathic effect caused by the virus
FRNT
(Focus reduction neutralization test)		 • Direct detection of viruses in cells
PBNA
(Pseudovirus-based neutralization assay)		 • Measurement method using Pseudovirus
• Vaccine for HPV
Functional antibody analysis SBA
(Serum bactericidal assay)		 • Evaluation of bacterial killing ability
• Vaccines for PCV, meningococcal, and typhoid fever
OPA
(Opsonophagocytic assay)		 • Confirmation of phagocytic ability
• Vaccines for PCV, meningococcal meningitis, etc.
Binding antibody analysis ELISpot
(Enzyme-linked immunospot)		 • Analysis of cytokines secreted by specific antigen stimulation
• Analysis at single cell level
• Vaccine for HAV
Management and distribution of cell lines for vaccine production / National cell line bank
  • Starting cell line distribution (since 2023) - 6 types of cell lines for vaccine production were transferred from the Ministry of Food and Drug Safety (MFDS)
  • Establishing characterization test methods related to cell line stability and conducting tests
  • Owned cell lines
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    Owned cell lines
    Vero MDCK MDCK(Suspension Cell) MRC-5 Hi-5(Srum-free) Hi-5
    MCB MCB MCB MCB MCB MCB
    WCB WCB WCB WCB WCB WCB

    * Master Cell Bank (MCB), Working Cell Bank (WCB)

  • Cell line distribution process

    Online application

    Acceptance

    Distribution screening

    Notification of results
    (Attached form)

    Fee payment

    Receipt

    Distribution

    Cell line receipt

  • Vaccines produced by cell line
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    Vaccines produced by cell line
    Cell line Product name Characteristics Development stage
    VERO InfluJect
    Celvapan
    PreFluCel
    Sinopharm
    Imogen    		 Vaccine against seasonal influenza
    Vaccine against pandemic influenza
    -
    Vaccine against coronavirus infection
    Live vaccine against Japanese encephalitis    		 Approved (NL), 2002
    Approved (EU), 2009
    Approved (AU), 2010
    Approved (WHO), 2021
    Approved
    MDCK Influvac
    Optaflu Flucelvax
    Celtura    		 World's first cell culture flu vaccine
    Seasonal influenza vaccine
    Flu vaccine    		 European marketing approval O, Launch X
    Approved (EU), 2007
    Approved (USA), 2012
    Approved (EU), 2009
    MDCK-SKY SKYCellflu Korea’s first cell culture influenza vaccine Approved (Korea), 2014
    MRC-5 Habrix Hepatitis A virus antigen Approved (USA), 1995