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GMP Facility

A Large-Scale Production Facility That
Complies with the GMP Standards of MFDS

CARTISTEM®, the world’s first allogeneic stem cell product, is being produced in the highly trusted, systemized pharmaceutical manufacturing facility that complies with the GMP standards of MFDS, the Pharmaceutical Inspection Convention, and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

AREA

  • 무균제조구역
    ASEPTIC PROCESSING AREA

    The Aseptic Operating Room are separated from Aseptic Culture Room to minimize cross-contamination

  • 무균준비구역
    ASEPTIC PREPARATION AREA

    A central monitoring system maintainsand manages the differential pressure,temperature, and humidity in theASEPTIC PROCESSING AREA

  • 무균시험구역
    ASEPTIC TEST AREA

    A separate testing room designed to
    conduct aseptic / other extraneous
    pollution source test to minimize
    cross-contamination

SYSTEM

  • 공기조화시스템

    공기조화시스템

    HVAC SYSTEM
    Total of 11 HVAC systems are being operated in order to maintain and manage the humidity & temperature.(10 in the processing area,
    1 in the testing area)
    A dedicated room using dedicated HVAC system is equipped to fundamentally block cross-contamination of raw materials.
  • 수처리시스템

    수처리시스템

    WATER TREATMENT SYSTEM
    A manufacturing/distribution system are set to stabilize purified water and supply it to the manufacturing facility.
  • 세포배양시스템

    세포배양시스템

    CELL CULTURE SYSTEM
    With 58 units of cell culturing incubator, a large quantity of cells are cultured safely.
  • 세포보관시스템

    세포보관시스템

    CELL STORAGE SYSTEM
    The cell storage tanks composed of the vacuum piping system are thoroughly maintained and managed.

CELL CULTURE & PRODUCT PROCESSING

MEDIPOST holds exclusive technologies in harvesting / large-scale culturing, maintaining viability and
characteristics of stem cells, as well as cryo-preservation, which are applied to the reliable manufacturing,
storage and release of stem cells for long-term regenerative treatment.

Manufacturing Management
All manufacturing processes are progressed through process validation.
Process Management
Validations on cell harvest, proliferation, freezing, drug substance manufacture processes,
Validations on subdividing substances, filling and labeling of drug product, Preparation of Manufacturing records
Sterility Management
Validation on
operator’s hygiene,
sterilization, and
cleaning process
Facility Management
Validation on
facility & equipment,
maintenance, and
cleanliness
Storage Management
Management of
shipping, receiving,
disposal, and collection
as well as temperature
maintenance of
raw materials /
semi-manufactures /
additional supplies
Quality Management
It is extremely important to perform proper evaluation of stem cells on the eligibility as a therapeutic drug.
Therefore, adequate tests are being conducted according to the regulations of Ministry of Food & Drug Safety and
Pharmacopoeia of Korea in order to consistently maintain the safety and effectiveness of cell therapeutic drugs.
We have established validation conditions for each product with different types of validation methods according to
international standards to manage the quality of our product. The stem cell therapeutic drug products undergo thorough
validation process before the release to the public.
Safety Test
A long-term stability test is implemented to secure the safety of the stem cell therapeutic drug in production.

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