Developers

An API for the physical batch.

Subscribe to fused PAT state, read predictions with the evidence behind them, and submit bounded control proposals — all through the same interface the console uses.

3client SDKs
1edge runtime
100%actions audited

Quickstart

Connect to a train in ten lines

Point the SDK at a plant-edge node, pick a train, and read the live state of the batch that is running right now.

from polymorra import Plant

plant = Plant.connect("edge://site-04", verify_tls=True)

for batch in plant.train("CR-2").stream():
    print(batch.step)                 # "antisolvent-addition"
    print(batch.state.supersaturation)
    print(batch.state.d50_um)
    print(batch.state.polymorph)      # ("Form II", 0.97)
    if batch.state.risk("oiling-out") > 0.2:
        batch.alert("oiling-out risk", severity="high")

Control

Proposals, not commands

The API never lets you write a raw setpoint. You submit a proposal; it is checked against the validated window for that train and routed for approval according to the configured autonomy level.

import { Plant } from "@polymorra/sdk";

const plant = await Plant.connect("edge://site-04");
const train = plant.train("CR-2");

const proposal = await train.propose({
  parameter: "jacket_ramp_c_per_min",
  target: 0.18,
  rationale: "FBRM counts rising above metastable limit",
  evidence: ["fbrm:2024-06-11T09:41Z", "raman:2024-06-11T09:41Z"],
});

// SHADOW -> logged only | ASSIST -> queued for chemist
// BOUNDED -> applied if inside validated window
console.log(proposal.disposition, proposal.auditId);

Edge runtime

Signed images, pinned models

The runtime is a signed container with a pinned, validated model bundle. Version changes are explicit, logged, and reversible — because in a GMP plant, silent updates are a finding.

$ polymorra edge status --train CR-2
runtime      1.8.3        (signed, verified)
models       crystallize-v4.2.1  [VALIDATED · locked]
             polymorph-v3.9.0    [VALIDATED · locked]
autonomy     ASSIST
streams      raman ✓  fbrm ✓  pvm ✓  nir ✓  dcs ✓
audit        append-only · 1,284,902 events · sealed
uptime       61d 04h  (last failover: none)

Surfaces

What you can build on

Everything is designed to be traceable: no output without evidence, no action without an audit id.

Batch state API

Fused PAT and telemetry state, streamed or polled, with unit-operation context.

Learn more

Prediction API

Polymorph, particle size, impurity, and endpoint predictions with confidence and cited evidence.

Learn more

Control proposals

Bounded setpoint proposals routed by autonomy level, always audited.

Learn more

Record & evidence

Query the Part 11 trail and export evidence packages for review or inspection.

Learn more

Twin API

Run profile simulations and scale-up predictions programmatically.

Learn more

Webhooks

Subscribe to deviations, form-transition risk, and autonomy changes.

Learn more

Plant-edge console

One screen for the batch that is running right now

Supersaturation, particle size distribution, predicted polymorph, impurity trajectory, and the next control move — with the evidence behind each number.

Polymorra plant-edge console showing live supersaturation, particle size distribution, predicted polymorphic form, and impurity trajectory for a running crystallization, with the recommended next control move.

Testing

A simulator so you never debug on a real batch

The twin doubles as a development target: replay historical campaigns, inject faults, and validate your integration long before it touches a qualified train.

  • Replay any recorded campaign deterministically
  • Inject oiling-out, fouling, seed drift, and sensor dropout
  • Assert on predictions and proposals in CI

Integrations

Connects to the systems already running your plant

Polymorra reads and writes through the reactor DCS, PAT instruments, crystallizer and isolation skids, historians, and MES you already validated.

Reactor control & DCS

Emerson DeltaVSiemens PCS 7Honeywell ExperionOPC UAModbus/TCP

PAT & analytics

Mettler-Toledo FBRMPVM in-situ imagingReactIREndress+Hauser RamanNIRHPLC / XRPD imports

Isolation & drying

Nutsche filter-dryersCentrifugesAgitated dryersConical millsMicronizers

MES, historian & quality

Körber PAS-XEmerson SyncadeOSIsoft PILIMSeBR / QMS exports

Trust & compliance

Validated for GMP manufacturing

Polymorra is engineered for regulated drug-substance production: grounded outputs, immutable audit trails, graduated autonomy, and validation documentation from day one.

21 CFR Part 11

Immutable, validated audit log for every agent perception, recommendation, and control action, with e-signature-ready review flows.

GMP / ICH Q7

Change control, validated model versioning, and deployment documentation designed for drug-substance manufacturing.

SOC 2

SOC 2 Type I in progress, Type II on the roadmap; SSO/RBAC, encryption in transit and at rest. [ASPIRATIONAL]

Route & IP protection

Per-tenant isolation of routes, recipes, spectra, and crystal images. No cross-tenant training. On-prem option.

Graduated autonomy

Shadow → assist → bounded auto-control. Every autonomy level is explicitly configured, bounded, and revocable.

Grounded outputs

Every recommendation cites the spectra, images, telemetry, SOP, or specification it was derived from.

Plant-edge first

Inference runs on-site so control loops survive network loss; cloud is for training, fleet, and analytics.

Human-in-the-loop

Chemist and QA checkpoints are first-class: approve, correct, or reject — and every correction trains the models.

Accelerated computing

An NVIDIA-accelerated stack, from the train to the fleet

Perception at the edge, reasoning in the cloud, and a reactor-and-crystallizer twin in between.

Stack

Jetson at the train

Plant-edge inference per reactor or crystallizer train: PVM crystal-image models, FBRM feature extraction, Raman and NIR soft sensors, anomaly and safety classifiers. [ASPIRATIONAL]

Stack

TensorRT + Holoscan

Low-latency perception and sensor-stream preprocessing for in-situ imaging and PAT spectra inside validated control windows.

Stack

Triton + NIM

Route-specific polymorph, impurity, particle-size, endpoint, and batch-reasoning models served with validated version locks and rollback.

Stack

Omniverse + Cosmos

Reactor-and-crystallizer twin plus synthesis of rare crystallization faults — oiling-out, fouling, seed drift, wrong-polymorph nucleation. [ASPIRATIONAL]

Stack

RAPIDS + cuOpt

Telemetry ETL at campaign scale, plus scheduling, solvent recovery, and crystallization-profile optimization.

Stack

NeMo + DGX

Fine-tuned chemistry-process and batch-record reasoning trained on de-identified design-partner data and chemist corrections. [ASPIRATIONAL]

FAQ

Frequently asked questions

Both — in a deliberate order. Polymorra starts in shadow mode (perceive only), moves to assist (recommend, chemist approves), then to bounded auto-control on qualified trains where setpoint moves stay inside validated control windows. Every level is configured per train and revocable.

Polymorra is built for GMP (ICH Q7) and 21 CFR Part 11: immutable audit trail, validated model version locks with rollback, change control, grounded and citable outputs, and human-in-the-loop checkpoints. We ship a validation package and support IQ/OQ/PQ activities with your quality unit.

API or OPC access to your reactor DCS, PAT instruments (Raman, FBRM, PVM, NIR), crystallizer and isolation skids, and MES or historian — plus a train with enough campaign volume for clear ROI.

No. Per-tenant isolation of routes, recipes, spectra, and crystal images is enforced at the data and model layer. Cross-site benchmarks are opt-in and de-identified.

A typical wedge pilot instruments one train, runs shadow mode over a baseline campaign, then moves to assist mode with a defined polymorph, yield, or reprocessing success metric agreed up front.

Perception and control inference run at the plant edge. Cloud handles training, fleet management, and analytics — losing it degrades reporting, not the batch.

Start in shadow mode. Break nothing.

Start with one crystallizer or reactor train. Prove polymorph, yield, and reprocessing ROI in a validation-friendly pilot. Then expand across the plant.