Every stage of the therapy journey, under continuous watch.
ATMPs move through six critical stages from R&D to patient follow-up. XiltriX maps the whole journey, watches the cleanrooms, bioreactors, and LN₂ tanks, and escalates deviations before they become product losses.
Protecting your therapies, from lab to patient.
A cell or gene therapy depends on tightly controlled conditions from the first development batch to long-term patient sample storage. The sector card below maps the operational journey in six stages: the key processes, the rooms, the equipment that must stay within range, the environmental parameters to watch, the standards that apply, and where XiltriX adds value. It is the same map our engineers use when designing a monitoring system for a therapy's unique GxP pathway.
Six stages, one monitoring map.
Select a stage to see the processes, locations, equipment, parameters, standards and XiltriX value for that stage.
Process development
Key processes
- Cell line development
- Process development
- Method validation
- Quality control
Locations
- R&D laboratories
- Process development suites
- QC labs
- Cleanrooms (research)
Assets to monitor
- Incubators (CO₂/O₂)
- Bioreactors
- Cleanroom environments
- Critical research equipment
Environmental parameters
- Temperature
- Humidity
- CO₂/O₂
- Particles (non-viable & viable)
Compliance & standards
- GLP (research phase)
- Data integrity (ALCOA+)
- Environmental control
- Audit & documentation
XiltriX value
- Real-time monitoring in R&D
- Early warning for research material
- Supports method validation
- Audit-ready data & reporting
Beyond monitoring.
The monitoring system is only part of the answer. XiltriX adds the IT and validation expertise that regulated cell and gene therapy labs need.
IT expertise
SSO with Active Directory, ISO 27001, full encryption, and a REST API that connects to LIMS, BMS and EMS.
Consultancy and validation
Risk inventory, URS and validation support (IQ/OQ), from design to inspection.
Visualisation, built in
Zoomable floor plans and live dashboards on any device, with wall screens built into your lab.
Proven where patient therapies are on the line.
Proven since 1987
No customer has lost irreplaceable material because our monitoring failed.
24/7 technical support
The monitoring chain is watched around the clock. Alarms escalate to your own on-call team.
Built for GxP
GMP, GDP, GCP and GLP: validated monitoring with full data integrity, ready for your next audit.
XiltriX detects, alerts and escalates through your own configured on-call contacts. Your team responds to alarms; the XiltriX 24/7 team keeps the monitoring system itself healthy.
Take the sector card with you.
The printable card summarises the six stages from development to patient follow-up, including the parameters and GxP standards for each. Share it with your quality team or bring it to your next project review.
Cell & gene therapy: monitoring the whole ATMP journey
What are the critical parameters to monitor for cell and gene therapy manufacturing?
Key parameters include temperature, humidity, differential pressure, and particle counts in GMP cleanrooms. For equipment, it's temperature in incubators, bioreactors, and freezers (down to -196°C in LN₂ tanks), CO₂ and O₂ levels, and LN₂ level and pressure for cryogenic storage. Monitoring power and door status is also vital.
Which GxP standards apply to cell and gene therapy monitoring?
The full GxP spectrum applies across the journey: GLP in development, GMP (including EU Annex 1) in manufacturing, GDP for transport, and GCP at clinical sites. A validated monitoring system must support data integrity (ALCOA+), provide complete audit trails, and help manage deviations and excursions.
How is long-term cryogenic storage of ATMPs monitored?
Cryogenic storage relies on independent sensors monitoring the LN₂ level, pressure, and auto-fill cycles of each storage vessel. This must be separate from the vessel's own controls to catch failures like a closed supply valve. Room conditions, power, and door access are also monitored to ensure unattended storage is secure 24/7.
Does XiltriX respond to alarms in our cell therapy lab?
No. XiltriX detects, alerts and escalates through your own configured on-call contacts, and your team decides who responds. The XiltriX 24/7 team is available when the monitoring system itself has a technical issue.
Ready to protect your therapy's entire journey?
Tell us about your therapy and the GxP pathway you need to secure. We will map the critical monitoring points with you, from the R&D lab to the clinical site.