Donor drift isn't your assay. It's your operating model.
CROs carry method-bridging overhead because donor-derived material forces it. SpectraComp, ScatterBridge, ViaComp, and PhenoCytes remove the drift. The overhead goes with it.
Built for work that gets audited
Five things that matter when you're the one defending the assay to the sponsor's QA director.
Same SKU, same MFI in MESF/ABC, every shipment. So when an assay drifts, you have a clean answer when the sponsor asks where it came from.
Pick the control that matches the assay
Why CRO QA directors are looking again
Three reasons CRO bioanalytical teams are rebuilding their reference strategy.
CLSI H62 and ICH Q2(R2) define the validation work, but neither helps when there's no commercial reference for the marker. Cell mimics close that gap. The Ki-67 mimic developed with Cerba Research is one example of a rare-marker control built to support validation under H62 with a stable, defined MFI. Per-lot CoAs in MESF and ABC drop into the sponsor's bioanalytical method file without a rewrite.
Looking for custom biomarker controls? We'll engineer it.
Tell us what you need.