Home/Infrastructure
Every instrument on the
critical path is qualified
Installation, operational and performance qualification records, plus a calibration schedule owned by Quality Assurance rather than by the people using the equipment.
Facility 01
GMP cell processing suite
Cell-based therapy is unforgiving of shortcuts. Our clean-room suite is built as a pressure cascade: air flows outward from the cleanest zone, so contamination cannot travel inward.
- Class 10,000 environment with Grade A laminar workstations for every open processing step.
- Segregated corridors for donor and patient material, eliminating cross-contamination routes entirely.
- Continuous monitoring of particulates, differential pressure, temperature and humidity, alarmed to on-call staff.
- Gowning airlocks with competency-verified entry for every operator.
99.4%uptime 2025
Facility 02
Analytics & characterisation
A cellular product is only as good as your ability to prove what is in it. Our analytics suite exists to answer that question before anything reaches a patient.
- Multi-laser flow cytometer with daily bead-based performance tracking for immunophenotyping.
- Molecular and genomics bench for expression profiling, sterility and mycoplasma screening.
- Confocal and live-cell imaging for morphology, migration and tracking studies.
- Potency assay development — measuring biological activity, not just cell count.
Facility 03
Biobank & cryostorage
Long-term storage sounds mundane until a vessel fails. Ours are engineered so that no single failure can lose a sample.
- Vapour-phase nitrogen with automatic top-up and continuous level monitoring.
- Redundant alarming to on-call staff by SMS and phone, tested monthly.
- Backup generator supporting the entire cryogenic and monitoring load.
- Complete chain of custody — every sample traceable to donor, operator, reagent lot and recipient.
100%sample integrity
Equipment Register
What we run, and how often it is checked
An extract from the qualification register. The full register is available to auditors and collaborators on request.
| Equipment | Function | Qualification | Check interval |
|---|---|---|---|
| Biosafety cabinets (Class II A2) | Aseptic open processing | IQ / OQ / PQ | 6 months |
| CO₂ incubators | Cell culture & expansion | IQ / OQ / PQ | 3 months |
| Multi-laser flow cytometer | Immunophenotyping | IQ / OQ / PQ | Daily beads |
| Refrigerated centrifuges | Cell separation | IQ / OQ | 6 months |
| Closed-system cell washer | Product washing | IQ / OQ / PQ | 3 months |
| Vapour-phase cryo vessels | Long-term storage | IQ / OQ / PQ | Continuous |
| Confocal microscope | Imaging & tracking | IQ / OQ | 12 months |
| Environmental monitoring system | Particulates & pressure | IQ / OQ / PQ | Continuous |
- 0+Specialised Labs
- 0Qualified Instruments
- 0Trained Operators
- 0/7Environmental Monitoring
Auditing us, or partnering with us?
We share our qualification register, SOP index and environmental data with auditors and research collaborators.