GMP Cell Manufacturing Facility

MEDIPOST’s stem cell manufacturing (GMP) facility offers large, industrial-scale production capacity in compliance with the GMP standards of the Ministry of Food and Drug Safety of Korea.

CARTISTEM®, allogeneic cord blood-derived mesenchymal stem cell product, is produced and commercially released from the MEDIPOST’s state-of-the-art GMP manufacturing through Quality Management System(QMS) for high-standard pharmaceutical manufacturing facility in compliance with the GMP standards of the Ministry of Food and Drug Safety(MFDS) of Korea and the Pharmaceutical Inspection Co-operation Scheme(PIC/S).

Manufacturing & QC Zones

Aseptic Manufacturing (Cell Processing) Zone

Aseptic manufacturing zones is further sub-divided into aseptic cell culture (incubator) room and aseptic cell processing (handling within the Biosafety Cabinets) room to further minimize the risks of cross-contamination.

Support Systems

HVAC(Heating Ventilating and Air Conditioning) Systems

A total of 11 independent HVAC units (10 for manufacturing zones and 1 for QC zone) are in operation to maintain the temperature and humidity. The dedicated and independent HVAC unit per each cleanroom zone allows virtually no risk of cross-contamination between cleanroom zones.

Cell Culture & Product Processing

MEDIPOST holds exclusive technologies relating to stem cell separation, cell characterization, mass culture while maintaining high cell viability, and cryopreservation, which are then applied to the manufacturing, storage and delivery logistics of cell therapeutics utilized in the field of regenerative medicine.

All manufacturing processes are performed following thorough Process Validation steps.

· Cell Production Process Management

Validations are performed on cell separation, mass culture and cryopreservation steps followed by cell harvest, filling and labeling of cells prepared as drug substance.

· Sterility Assurance and Environmental Monitoring

Validations are performed on the operators’ hygiene, sterilization and cleaning processes in combination with real-time constant monitoring of the workspace and periodic monitoring of the surrounding areas within the cell manufacturing GMP facility.

· Facility Management

Validations are performed on facility and equipment, maintenance standards and cleanliness.

· Storage Management

Management systems are in place for raw and ancillary materials for the collection/receipt, quarantine/storage, release and disposal, including appropriate temperature maintenance of raw materials, and semi-finished products prepared as drug substance.