<10% CV
Same sites, same instruments, same panels. When the control stops contributing noise, the variance you see is the biology — which is what you wanted to measure in the first place.
- CD19
- BCMA
- EGFR
Cell biology has a reproducibility problem. The field has been working on it for forty years and the numbers haven't moved. The 2016 Nature survey put it at 70% of researchers unable to reproduce another scientist's experiments. More than half couldn't reproduce their own.
That's not a protocol problem. It's a materials problem.
What matters when your assay has to hold up across operators, sites, audits, and the next ten years of comparability.
The same SKU, the same antigen density, the same scatter profile, every shipment. So when an assay shifts, you know it's the assay, not the control.
Cellares built Cell Q™, the automated QC platform for their Cell Shuttle™ manufacturing system — the first cell therapy manufacturing system to receive FDA Advanced Manufacturing Technology (AMT) designation. They chose TruCytes® as the reference material that runs inside it.
Donor material varies run to run. An automated QC workflow can't tolerate that drift. Engineered cell mimics are the only reference material that holds consistent by design.
From potency assay development through commercial release across global sites, the reference material has to hold. Here's where it usually doesn't, and where it stops.
Five families that solve five parts of the same problem: making CGT flow data reproducible from preclinical through release.
Three things you can verify before the next program review.
<10% CV
Same sites, same instruments, same panels. When the control stops contributing noise, the variance you see is the biology — which is what you wanted to measure in the first place.
Lot-to-lot consistency that holds from Phase I through commercial release. No re-qualification when phases change or scale shifts.
Same control, same reading, whether the run happens in Boston, Munich, or Singapore. Instrument-to-instrument noise collapses.
Frequently asked questions to our team.
Tell us what you're trying to measure. We usually answer within a day.