PREDICTIVE RISK SCORING
Micro, bioburden and stability risk scored per batch from process signatures, not just from the assay that has not come back yet.
STAGE 04 // ASSURE
Serumon’s assurance layer. Stabion fuses bioburden, preservative-efficacy and stability signals with the make-and-fill context from Emulson, Shadera and Fillix into a single predictive batch-safety picture — forecasting risk early, recommending hold or release, and assembling the GMP-grade evidence pack.
$ stabion assess --batch B-24118 MICRO RISK 0.04 (low) conf 0.93 PRESERVATIVE EFF PASS-LIKELY conf 0.89 STABILITY 24M WATCH conf 0.77 driver: emulsification held upper shear band driver: phase B temp excursion +1.2C @ t+13:20 RECOMMENDATION RELEASE WITH FLAG EVIDENCE PACK 42 artefacts, 100% cited OPEN DEVIATIONS 0 > awaiting QA signature (dual approval)
THE PROBLEM
Every cosmetics batch must prove microbiological safety, preservative efficacy and stability under GMP (ISO 22716) before release. Contamination or a stability failure triggers holds, re-tests and recalls.
Lab QC is slow, reactive and disconnected from the make-and-fill signals that actually predict risk. Release decisions rest on scattered lab results and human judgement, so plants sit on held inventory and discover failures late.
The signals that would have predicted the failure were recorded during compounding — nobody was fusing them.
HELD INVENTORY REALITY
ILLUSTRATIVE SITE FIGURES [ASPIRATIONAL UNTIL MEASURED].
CAPABILITIES
Micro, bioburden and stability risk scored per batch from process signatures, not just from the assay that has not come back yet.
Dose, emulsification, shade and fill signals joined to lab results so causality is visible instead of inferred.
Hold or release recommendations with a GMP-grade, fully cited evidence pack attached — ready for QA signature.
Preservative-efficacy and stability trend analysis across formulas, packs and markets.
Immutable, aligned traceability from raw-material lot through compounding, fill, pack and release.
Grounded language-model drafting of deviation narratives with citations back to the underlying batch evidence.
THE LOOP
Lab assays, environmental monitoring and stability studies are joined to the batch’s make-and-fill telemetry.
Multimodal risk models score micro, preservative efficacy and stability, each with an explicit confidence.
Drivers are surfaced as concrete process events, not feature weights: which excursion, at which minute, on which phase.
A recommendation plus a cited evidence pack goes to QA. The human signs; the system records who, when and on what basis.
AI CAPABILITIES
Serumon labels its own maturity. Anything not yet validated in production is marked aspirational, on this site and in the room.
REAL / PARTLY ASPIRATIONAL
Fusion of process telemetry and lab assays is real where data exists; predictive lead-time claims depend on accumulated outcomes.
REAL
Time-series shelf-life and stability trend models across formula and pack combinations.
REAL
Retrieval over GMP and micro/stability SOPs with enforced citations. Answers without sources are refused.
REAL
Grounded language-model reasoning over batch records for deviation write-ups and investigation support.
NVIDIA ALIGNMENT
Train multimodal risk and prognostics models across process telemetry, assays and stability studies.
Edge-side fusion so risk scores exist before the batch leaves the vessel.
GPU-accelerated feature pipelines over high-volume batch and environmental telemetry.
Self-hosted, grounded reasoning models for regulated environments where data cannot leave the site.
MEASUREMENT
PILOTS ARE CONTRACTED AGAINST A NAMED ROI METRIC AND A BASELINE WE RECORD BEFORE ANYTHING CHANGES.
THE MOAT
LIMS and QMS vendors hold the assay result. Equipment vendors hold the process trace. Neither holds both, joined per batch, over years, with the release outcome attached.
Stabion sits exactly at that junction. Each batch adds one labelled example linking how the product was made to whether it survived, which is the only dataset that makes early risk prediction real.
DEPLOYMENT SHAPE
ECOSYSTEM
Every agent hands the next one a better decision. Buy one; the others make it sharper.
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STABION FAQ
No. A qualified person signs release. Stabion produces the recommendation, the confidence and the cited evidence pack that makes the human decision faster and better documented.
No. Your LIMS remains the system of record for assays. Stabion reads from it, fuses those results with process context, and writes back its assessment and evidence pack.
Uncertainty is a first-class output. Below the confidence threshold the recommendation is explicitly "insufficient evidence", which routes to the standard lab-led decision path rather than guessing.
Serumon is designed to be auditable: immutable logs, versioned models, replayable batches and enforced citations. The AI advises inside your existing quality system; it does not replace your approvals or your documented procedures.
WEDGE PILOT
Instrument, baseline, shadow, then assist — against a metric you name before we start. If the numbers do not move, you have lost a quarter of telemetry and gained a very detailed picture of your own process.