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 and only 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:
Entrance to our cGMP facilities
Cryogenic Storage
CliniMacs Prodigy® –
An Automated Cell Processing Platform
Nucleofector
Operation in Biological Safety Cabinets
(BSCs)
MACSQuant® Analyzer (Flow Cytometer)