STAGE 04 // ASSURE

Stabion
clears the batch.

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.

ISO 22716ALIGNED AUDIT
PREDICTIVEMICRO RISK
CITEDEVIDENCE PACKS
DGX + JETSONGPU PROFILE
stabion — batch B-24118 release view
$ 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)
PREDICTIVE RISK SCORINGCROSS-STAGE FUSIONRELEASE RECOMMENDATIONSHELF-LIFE INTELLIGENCEISO 22716 AUDIT TRAILDEVIATION WRITE-UPS

THE PROBLEM

Release is a lagging lab gate on a leading process

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

AVG HOLD
3–10 DAYS
RE-TEST CYCLES
1–3
LATE FAILURE COST
10–40x
SIGNALS AVAILABLE
AT MAKE TIME
SIGNALS USED
ALMOST NONE

ILLUSTRATIVE SITE FIGURES [ASPIRATIONAL UNTIL MEASURED].

CAPABILITIES

What Stabion does

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.

CROSS-STAGE FUSION

Dose, emulsification, shade and fill signals joined to lab results so causality is visible instead of inferred.

RELEASE RECOMMENDATION

Hold or release recommendations with a GMP-grade, fully cited evidence pack attached — ready for QA signature.

SHELF-LIFE INTELLIGENCE

Preservative-efficacy and stability trend analysis across formulas, packs and markets.

ISO 22716 AUDIT TRAIL

Immutable, aligned traceability from raw-material lot through compounding, fill, pack and release.

DEVIATION WRITE-UPS

Grounded language-model drafting of deviation narratives with citations back to the underlying batch evidence.

THE LOOP

Four beats, every batch

  1. 01

    INGEST

    Lab assays, environmental monitoring and stability studies are joined to the batch’s make-and-fill telemetry.

  2. 02

    SCORE

    Multimodal risk models score micro, preservative efficacy and stability, each with an explicit confidence.

  3. 03

    EXPLAIN

    Drivers are surfaced as concrete process events, not feature weights: which excursion, at which minute, on which phase.

  4. 04

    RELEASE

    A recommendation plus a cited evidence pack goes to QA. The human signs; the system records who, when and on what basis.

AI CAPABILITIES

What is real today, and what is not

Serumon labels its own maturity. Anything not yet validated in production is marked aspirational, on this site and in the room.

REAL / PARTLY ASPIRATIONAL

MULTIMODAL RISK MODELS

Fusion of process telemetry and lab assays is real where data exists; predictive lead-time claims depend on accumulated outcomes.

REAL

STABILITY PROGNOSTICS

Time-series shelf-life and stability trend models across formula and pack combinations.

REAL

REGULATORY RAG

Retrieval over GMP and micro/stability SOPs with enforced citations. Answers without sources are refused.

REAL

BATCH-RECORD REASONING

Grounded language-model reasoning over batch records for deviation write-ups and investigation support.

NVIDIA ALIGNMENT

GPU is must-have, not nice-to-have

DGX / HGX

Train multimodal risk and prognostics models across process telemetry, assays and stability studies.

JETSON

Edge-side fusion so risk scores exist before the batch leaves the vessel.

RAPIDS

GPU-accelerated feature pipelines over high-volume batch and environmental telemetry.

NEMO + NIM

Self-hosted, grounded reasoning models for regulated environments where data cannot leave the site.

MEASUREMENT

What we get judged on

HOLD DAYSPRIMARY METRIC
LATE FAILURESSECONDARY METRIC
RELEASE CYCLETHIRD METRIC
$9k/moLINE TIER PRICE

PILOTS ARE CONTRACTED AGAINST A NAMED ROI METRIC AND A BASELINE WE RECORD BEFORE ANYTHING CHANGES.

THE MOAT

Nobody else has the make signals and the outcome

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.

  • Process signatures paired with micro and stability outcomes.
  • Preservative-efficacy behaviour by formula and pack.
  • Deviation histories with the resolution that worked.
  • Release decisions and their downstream consequences.

DEPLOYMENT SHAPE

TIER
LINE / PLANT / ENT
LINE PRICE
$9,000 / mo
PLANT PRICE
$60,000 / mo
ENTERPRISE
$400k–$5M ACV
EDGE NODE
PER VESSEL CLUSTER
AUTONOMY
GRADUATED

ECOSYSTEM

How STABION plugs into the loop

Every agent hands the next one a better decision. Buy one; the others make it sharper.

STABION FAQ

Straight answers

WEDGE PILOT

Run Stabion on one line

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.