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Bioassay & Potency

Bioassay and potency LIMS for release testing

Cell-based, binding, qPCR, flow, and SPR potency assays with plate map generation, reader integration, relative potency analysis, and system suitability enforcement.

THE PROBLEM

Where legacy LIMS break down

Potency is the release test that takes the longest and fails the most. Cell-based assays run over days, reference standard performance drifts, and the relative potency calculation has parallelism and system suitability criteria that have to pass before the number means anything.

The statistics live in PLA or SoftMax. The LIMS gets a number. When a lot fails potency, the investigation has to reconstruct plate layout, reference standard lot, and curve fit from the analysis software and the notebook.

Labbit generates the plate map, captures raw reader data, hands off to the statistical layer, and pulls the relative potency result back with the parallelism and suitability outcomes attached. Reference standard lots and cell bank passages are tracked per assay so drift is visible.

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PRE-CONFIGURED WORKFLOWS

Workflows out of the box

Built visually in BPMN, adapted to your lab, and changed without a vendor release.

Cell-Based Potency Assays; ELISA Binding & Potency; qPCR-Based Potency / Identity; Flow Cytometry Potency / Identity; SPR / Binding Kinetics; Relative Potency Data Analysis
Targeted Amplicon Sequencing

Instruments and platforms

Instruments and platforms

BioTek Cytation; Molecular Devices SpectraMax; Promega GloMax; Tecan Spark; Bio-Rad CFX Opus; BD FACSLyric; Beckman CytoFLEX; Cytiva Biacore T200 and 8K
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FAQ

Frequently Asked Questions

Does Labbit integrate with PLA and SoftMax Pro for relative potency?

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Yes. Raw data hands off to the statistical layer and relative potency, parallelism, and system suitability results return to the sample record.

Which readers and platforms are supported?

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BioTek Cytation, Molecular Devices SpectraMax, Promega GloMax, Tecan Spark, Bio-Rad CFX for qPCR potency, BD and Beckman cytometers for flow potency, and Cytiva Biacore for SPR.

Can Labbit track reference standard and cell bank performance?

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Yes. Reference standard lots and cell bank passages are tracked per assay with performance trending.

Is bioassay data Part 11 compliant in Labbit?

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Yes. Electronic records and signatures, role-based review, and complete audit trail across raw data, analysis, and result.

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SEE IT ON YOUR ASSAYS

See your workflow running in Labbit

Bring an assay your team runs today. We’ll show you how it’s configured, executed, and reviewed.