Facility

OCELLBIO has designed a cleanroom suite for human cell processing, storage and quality control on the fourth floor of its headquarters and is preparing for construction. Based on the layout drawing prepared in July 2026, the clean zone covers approximately 86㎡ within a band measuring 15,150mm wide by 5,700mm deep.

Two principles guide the design. First, the zone handling clinical-grade cells is separated from the research and training zone down to access routes, equipment and air handling. Second, we avoid over-investing in manufacturing equipment at the outset while leaving headroom in HVAC, power, piping and circulation so the space can later expand into a licensed facility.

Fourth-floor GMP layout

Clean band 15,150mm wide × 5,700mm deep · clean zone approx. 86㎡

Rooms and target cleanliness grades

Areas and target cleanliness grades follow the fourth-floor GMP layout drawing prepared in July 2026. Final grades will be confirmed through construction consultation and performance verification, and may be adjusted where closed systems are applied.

Construction scope

• Cleanroom panels, ceilings, doors and view windows
• Flooring (conductive tile / epoxy)
• HVAC, constant temperature and humidity units, ductwork
• HEPA filters / FFU
• Differential pressure design, temperature, humidity and pressure monitoring
• Electrical, lighting and fire protection
• Piping (water supply and drainage, gas, CDA)
• 2 pass boxes and air shower
• IQ / OQ / PQ validation
• Cleanliness performance verification (particles, viable counts, pressure, air velocity)

Cold chain and storage equipment

• Vapor-phase liquid nitrogen storage tanks
• -80℃ ultra-low freezers (primary unit plus emergency backup)
• -20℃ freezer / 2–8℃ medical refrigerators
• Calibrated independent temperature sensors and door-open alarms
• Oxygen depletion sensors and forced ventilation
• UPS and emergency power connection
• 24-hour remote temperature monitoring and alarms
• Dry shippers and temperature data loggers
• Barcode printers and scanners, tamper-evident seals
• LIMS-based inventory management down to storage position

Operating principles

• Clinical-grade cells are received, stored and released in sealed condition only
• No thawing, washing, aliquoting, mixing or repackaging
• Released and non-released cells stored separately
• Autologous and allogeneic cells stored separately
• Normal product separated from returned or temperature-excursion product
• Research zone operated with separate access and dedicated equipment
• Research-use products kept labeled as not for human administration
• Quality records retained for 10 years from the final supply date

Facility expansion roadmap

1. Phase 1

   Cell logistics and quality hub

   Approx. 115–150㎡

   Order and schedule management, collection kit supply, receipt of sealed product, short-term cryogenic storage, hospital release, cold chain, quality documentation, recall response and clinician training. No cell culture, isolation or aliquoting is performed.

2. Phase 2

   Logistics hub plus research and training culture room

   Approx. 150–200㎡

   Adds research-grade mesenchymal stem cell culture, media comparison, post-thaw viability testing, joint research and clinician training. Facilities, equipment and circulation for clinical and research use remain clearly separated.

3. Phase 3

   Independent licensed cell processing facility

   Approx. 265㎡ and above

   Once monthly throughput and partner hospitals are sufficient and a quality officer and specialist staff are in place, the site expands into an independently licensed facility with raw material receiving, quarantine storage, graded manufacturing zones, airlocks and pass boxes, freezing and filling rooms, and environmental monitoring.