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).
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
- Facility Management
- Validation on
facility & equipment,
- Storage Management
- Management of
disposal, and collection
as well as temperature
raw materials /
- 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.