Autonomous API manufacturing

The plant that makes the medicine should run itself.

Polymorra is the autonomous operations layer for pharmaceutical API and small-molecule drug-substance manufacturing — agents that control the reaction, land the target polymorph, protect the crystal through isolation, and write the record as they go.

7autonomous agents
4PAT modalities fused
24/7plant-edge control

Built for the plants that make the world’s small molecules

  • Branded pharma
  • Generics
  • CDMOs
  • Fine chemicals
  • Peptide APIs
  • High-potency APIs
  • Continuous plants

The problem

Crystallization is still run by feel

The most valuable step in the pharmaceutical supply chain — the one that decides polymorph, particle size, purity, and whether the batch is releasable — is still governed by a fixed cooling ramp and an experienced chemist watching a trend line.

  • Wrong polymorph means a failed batch, a reprocess, or a recall
  • Particle size drives dissolution, bioavailability, and downstream formulation
  • Off-spec impurities are discovered offline, hours after the decision that caused them
  • Tech transfer from lab to plant loses the crystal that development worked for years to find

The autonomous loop

Perceive, plan, act, sense, optimize, log

Polymorra closes the loop around the reaction mass and the crystal — the two things a conventional DCS cannot actually see.

  1. Perceive

    Fuse Raman, FBRM, PVM in-situ imaging, NIR, and reactor telemetry into a live picture of the reaction mass, slurry, and solids.

  2. Plan

    Plan the react-and-charge, crystallize-and-seed, and isolate-and-dry moves for this batch against the target polymorph, particle size, and purity.

  3. Act

    Run with adaptive control: cooling and antisolvent profile, seeding, supersaturation, agitation, addition rate, and endpoint.

  4. Sense & predict

    Predict polymorph, particle size and habit, impurity profile, and yield in-line — before offline XRPD and HPLC confirm it.

  5. Optimize

    Optimize yield, solvent use, cycle time, and reprocessing risk across the campaign, then flag off-spec and polymorph risk early.

  6. Log & retrain

    Write an immutable Part 11 record; every chemist correction trains the site model and compounds the data moat.

Agents

Seven agents run the plant from charge to release

Each agent owns a unit operation, is bounded by validated control windows, and hands off to the next with full traceability.

React-and-charge agent

Controls reagent and solvent charging, temperature, pH, and addition rate to hit target conversion and impurity profile — not just hold a setpoint.

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Crystallize-and-seed agent

Controls the cooling and antisolvent profile, seeding, supersaturation, and agitation to land the target polymorph, particle size, habit, and purity.

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Purity-and-polymorph agent

Senses and predicts polymorphic form, particle size and habit, and chemical, chiral, and genotoxic impurities from Raman, FBRM, PVM, and NIR fusion.

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Isolate-and-dry agent

Controls filtration, washing, drying, and milling to spec — protecting the crystal you just made through the hardest downstream steps.

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Robot-and-sampling agent

Drives robotic sampling, reagent charging, and material handling so the loop closes without exposing operators to the reaction mass.

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Flow-and-continuous agent

Optimizes continuous-flow and continuous-crystallization operation, holding the operating window through disturbances.

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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.

Digital twin

Simulate the crystal before you make it

A reactor-and-crystallizer twin lets you rehearse a cooling and antisolvent profile, a seeding strategy, or a scale-up in simulation — including the rare faults you never want to see live: oiling-out, fouling, seed drift, and wrong-polymorph nucleation.

  • Predict the plant crystal from the lab crystal for faster tech transfer
  • Stress-test a profile against disturbances before it touches a batch
  • Train agents on synthetic faults that almost never appear in real data [ASPIRATIONAL]

Why it matters

The API plant is the most valuable, least autonomous step in pharma

7autonomous agents from charge to release
4PAT modalities fused in-line (Raman · FBRM · PVM · NIR)
24billion-dollar TAM across API automation and control
134% net revenue retention target as plants expand

Market figures are internal estimates from our TAM/SAM/SOM analysis. Product performance figures are design targets. [ASPIRATIONAL]

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.

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

Voices from the plant

What operators say

Composite quotes from design-partner discovery interviews. [PLACEHOLDER — to be replaced with named references post-pilot]

“The crystallization step is where our campaigns live or die. Seeing supersaturation, particle size, and predicted polymorph in one place — and having the profile adjust itself — is what we have wanted for twenty years.”
Crystallization & PAT EngineerTop-20 branded pharma · API site
“We do not want another dashboard. We want the batch to come out right and the record to be reviewable by exception. That is the only pitch that gets past QA.”
QA / Regulatory ManagerGeneric API manufacturer
“Tech transfer is our bottleneck. If the twin can predict the plant crystal from the lab crystal, that is worth more than the software costs.”
API Manufacturing DirectorGlobal CDMO

Every crystal, perfectly formed.

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