Solutions

Different plants. Same unforgiving crystal.

Branded pharma, generics, CDMOs, and fine chemicals face the same physics with different economics. Polymorra lands wherever the batch is losing you the most money.

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

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

By workflow

Where teams start

Most sites land on crystallization first — it has the sharpest failure mode and the clearest ROI.

Workflow

Crystallization control

Land the target polymorph, particle size, and habit batch after batch instead of hoping the ramp holds.

Workflow

Reaction control

Drive conversion and impurity profile with adaptive charging, temperature, and pH.

Workflow

Isolation & drying

Protect form and particle size through filtration, washing, drying, and milling.

Workflow

Continuous manufacturing

Hold the operating window in flow chemistry and continuous crystallization.

Workflow

Tech transfer & scale-up

Predict the plant crystal from the lab crystal with the twin.

Workflow

Batch release

Review by exception with a Part 11 trail behind every deviation.

By organisation

Built for four kinds of buyer

The physics is shared; the business case is not.

Branded pharma

Protect a high-value molecule: polymorph consistency, supply reliability, and inspection readiness on a product where a failed batch is worth millions.

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Generic manufacturers

Compete on cost: yield, cycle time, solvent recovery, and reprocessing reduction across high-volume campaigns.

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CDMOs

Win and keep contracts: faster tech transfer, repeatable quality across clients, and evidence you can show in a customer audit.

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Fine chemicals & intermediates

Bring pharma-grade crystallization control to adjacent high-value chemistry.

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Polymorph risk

The failure mode nobody wants to explain

A wrong or converting polymorph can invalidate a batch, trigger a reprocess, threaten bioavailability, and in the worst case reach the market. Polymorra predicts form in-line and steers the profile away from the transition before it happens.

  • In-line form identification with cited spectra
  • Transition and oiling-out risk flagged during the run
  • Twin-based rehearsal of profiles on new routes

Yield & solvent

Money that leaves in the mother liquor

Small improvements in yield, cycle time, and solvent recovery compound across a campaign. Polymorra optimizes the profile and the schedule together instead of treating them as separate problems.

  • Campaign-level sequencing and changeover optimization
  • Solvent recovery modelled with the crystallization, not after it
  • Reprocessing risk scored before the batch is committed

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.

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.

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.

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

Tell us which step hurts most.

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