GMP Center – MEDIPOST

GMP Center

MEDIPOST’s GMP Center 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).

Location of GMP Center

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.

Aseptic Zone Monitoring System

The central and real-time monitoring and logging system is in operation 24/7, in order to monitor and manage pressure differentials, temperature and humidity in each individual aseptic manufacturing (cell processing) zones.

Aseptic Quality Control(QC) Testing Facility

For in-house Quality Control testing for sterility and other extrinsic contaminants, independent aseptic clean zones are designed to eliminate the possibility 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 Capacity

A total of 58 large-scale cell culture incubators are in operation, allowing large-scale and stable cell culture capabilities.

Cryopreserved Cell Storage System

Processed cells are cryopreserved and stored in liquid nitrogen(LN₂) storage vessels with a centralized, vacuum piped LN₂ supply system for stable and storage and monitoring.

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.

Quality Assurance

It is crucial that the proper evaluation steps are performed on the stem cells for their eligibility as a therapeutic agent. Therefore, adequate tests are being conducted according to the regulatory requirements of the Ministry of Food & Drug Safety and Pharmacopoeia of Korea in order to maintain safety and consistent effectiveness of cell therapeutics manufactured at MEDIPOST. We have established validation conditions for each product with different types of validation methods for quality assurance, and only the stem cell therapeutic batches which have met the validation conditions based on international standards are released to the public.

Stability Test

Long-term stability testing is performed periodically in order to confirm safety and effectiveness of cryopreserved stem cell therapeutics.