Our cGMP Facilities

Our brand new state-of-the-art current Good Manufacturing Practice (cGMP) facilities follow international standards specific for the complex manufacturing process of advanced therapy medicinal products to ensure quality, safety, and efficacy.

  • Designed to be compliant with United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), and Pharmaceutical Inspection Co-operation Scheme (PIC/S) for early phase clinical trial materials in the cell and gene therapy markets
  • ~22,000 ft² manufacturing facilities with cleanrooms, quality control, process development and research labs
  • HK’s first Grade A and B clean spaces
  • HK’s first multi-products cGMP manufacturing facility
  • Capability to introduce DNA, RNA or protein into cells
  • Cryogenic storage
  • Robust quality management system
  • 24-hour remote Environmental Monitoring System:
Xellera-Entrance
Entrance to our cGMP facilities
Grade-B-Cleanroom

Grade B Cleanroom

Cryogenic Storage
Environmental Monitoring during Manufacturing process

Environmental Monitoring during Manufacturing process

Nucleofector

Nucleofector

Operation in Biological Safety Cabinets
(BSCs)