Cell & Gene Therapy · San Diego, CA
Helix runs per-patient batch validation with vein-to-vein traceability
317
Patient batches validated
0
Chain-of-identity errors
<4 h
Release decision
The challenge
Autologous CGT manufacturer with batch size = 1. Each patient batch needs traceability from apheresis to infusion. Traditional CSV templates do not fit.
The approach
Helix Cell Therapy ran a focused 4-week proof-of-value with cGen, starting from the GxP application inventory. By the end of week two, every system in scope was registered, categorised under GAMP 5, and assigned an owner. The validation projects that were in flight were migrated into the platform during week three. By week four, the team was running the new Inspector Mode against a simulated FDA scenario.
The outcome
Custom CGT validation templates plus cGen AI risk assessor. Per-patient validation runs deterministically. Chain-of-identity and chain-of-custody captured automatically.
"cGen was the only platform we evaluated that did not flinch at batch-size-one. The CGT templates are not a marketing claim — they actually work."
What's next
Helix Cell Therapy is rolling cGen out across two additional sites in the next two quarters, and is one of the early-access programme's reference customers for the cGen three-stage rollout.
Could this be your story?
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