Cell and gene therapy validation
Running a cell or gene therapy program? Validate the systems that carry a therapy from collection to infusion. Identity- and safety-critical systems come first.
The challenges this solves
Chain of identity cannot fail
A single break between patient and product is a safety event.
Every batch is patient-specific
Generic batch record validation does not fit our process.
Many systems, one workflow
Apheresis, manufacturing, cryo and logistics systems must hand off data cleanly.
What we deliver
- Chain of identity and chain of custody (COI/COC) risk assessment
- ISBT 128 labeling verification
- Apheresis-to-infusion system validation
- Patient-specific MES and batch record validation
- Cryo and logistics tracking
- ALCOA++ data integrity evidence for COI/COC
- Integration validation across the workflow
- FACT and JACIE accreditation alignment
4 steps, clear deliverables
- 01
Map
Trace the patient-product-patient workflow.
You receive: CGT-specific validation plan
- 02
Assess
Risk-assess COI/COC and data integrity exposure.
You receive: Chain-of-identity and custody risk assessment
- 03
Validate
Prioritize identity- and safety-critical systems.
You receive: Test evidence and traceability matrix
- 04
Sustain
Maintain control across process and system change.
You receive: Audit-ready validation summary report
Want to know what this would take for your systems? Start with a short scoping call.
Who we do this for
- Cell & gene therapy
- Biotech
- Pharma & biopharma
Related services
Questions we hear most
What makes CGT validation different?
Each batch is tied to one patient. Chain of identity and custody must hold from collection through infusion.
Do you cover labeling and accreditation?
Yes. We verify ISBT 128 labeling and align systems with FACT and JACIE expectations.
How is the work priced?
Fixed-fee engagements with a defined price, scope and timeline. No open-ended hourly billing.
Validate your CGT workflow end to end
Get a scoped, fixed-fee quote from collection to infusion.