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Stem Cell GMP Center

We operate a state-of-the-art manufacturing facility with a total floor area of 2,635 m², located in Gwangmyeong, Gyeonggi-do, Korea.

Securing up-to-date cGMP-level production facilities

Capacity

Capacity

36,000 vials per year (based on finished drug products)

Dedicated HVAC

Dedicated HVAC

10 aseptic processing rooms and 3 aseptic laboratories Independent, dedicated HVAC systems for each area

Efficient Cell Culture Systems

Efficient Cell Culture Systems

Cell culture systems capable of manufacturing from small-scale to large-scale production

Reliable Manufacturing Support Utilities

Reliable Manufacturing Support Utilities

Dedicated dual power supply system to enhance power Stability. Uninterruptible Power Supply (UPS) systems in place

Cross-Contamination Prevention System

Cross-Contamination Prevention System

Air-tight doors installed to prevent cross-contamination between manufacturing rooms. Validated hydrogen peroxide (H₂O₂) fumigation system in operation

Regulatory Approvals & Certifications

Regulatory Approvals & Certifications

Cell Processing Facility License (MFDS), Advanced Biopharmaceutical Manufacturing License (MFDS), Human Cells and Tissues Management Business License (MFDS), Specified Cell Processing Product Manufacturing Certification (PMDA, Japan)

LIMS

LIMS

Operation of LIMS and barcode systems to enhance data integrity

Real time monitoring

Real time monitoring

Real-time monitoring systems for critical process parameters

Pharmaceutical transportation

Pharmaceutical transportation

Over 1,000 cumulative deliveries of clinical investigational products completed (as of December 2025; including refrigerated and frozen shipments)