Reactor control & DCS
Emerson DeltaVSiemens PCS 7Honeywell ExperionOPC UAModbus/TCP
FAQ
The questions plants ask on call one.
Autonomy, validation, integration, data protection, and commercials — answered directly.
Built for the plants that make the world’s small molecules
- Branded pharma
- Generics
- CDMOs
- Fine chemicals
- Peptide APIs
- High-potency APIs
- Continuous plants
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.
FAQ
Coverage and instrumentation
Reagent and solvent charging, reaction control, crystallization and seeding, isolation and filtration, washing, drying, and milling — plus continuous-flow and continuous-crystallization operation.
Usually some. Polymorra is strongest where in-line PAT exists — Raman, FBRM, PVM, and NIR. If a train is under-instrumented we scope the minimum probe set during the plant review rather than selling you a full suite.
It can still deliver record-and-review and telemetry-based reaction control, but crystallization autonomy depends on seeing the slurry. We will say so plainly rather than overpromise.
Models are route-specific and version-locked. Switching campaigns switches the validated model bundle, and the change is logged.
FAQ
Hardware, resilience, and data ownership
GPU-accelerated edge nodes sized per train — typically Jetson-class for perception with an on-site server for heavier inference and the local audit store. [ASPIRATIONAL for specific SKUs]
Control authority returns immediately to the DCS and the train continues on its last validated profile. Polymorra fails safe by design; it is never a single point of failure for the batch.
Yes. Model bundles are delivered as signed offline artifacts and the audit trail stays entirely on site.
You own your data and any site-specific model derived from it. Improvements to the base architecture are ours; your route knowledge stays yours.
Still deciding
The honest version
Polymorra is early. We are taking a small number of design partners, we mark aspirational claims as aspirational, and we would rather scope a narrow pilot that clearly works than a broad one that impresses in a slide and disappoints in a plant.
- Start on one train with one metric
- Shadow mode gives value before any control authority
- Every commitment is written into the pilot scope
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.
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.
Pricing
Land on one train. Expand to the plant.
Pricing follows the value of the batch: per reactor or crystallizer train, per plant, or an enterprise agreement with outcome components.
Line
Manufacturers validating ROI on the wedge workflow.
$13,000
per reactor or crystallizer train / month
- Reaction-control, crystallization/polymorph-control, or PAT-sensing AI for one train
- Plant-edge runtime with validated model versioning
- Connectors for one DCS, one PAT stack, and one MES
- Review console for chemists and PAT engineers
- Part 11 audit trail from day one
Most popular
Plant
Scaling plants adopting the full autonomous loop.
$85,000
per plant / month
- React-and-charge + crystallize-and-seed agents
- Purity-and-polymorph PAT sensing across trains
- Isolate-and-dry plus flow-and-continuous optimization
- Batch-record review by exception
- Reactor-and-crystallizer digital twin
- Campaign scheduling and solvent-recovery optimization
Enterprise
CDMOs and pharma networks standardizing on Polymorra.
Custom
land $600k – $7M ACV
- Multi-site deployment and plant-edge fleet management
- Custom route, crystallization, and impurity models
- Validation support and qualification documentation
- On-prem or hybrid deployment with NVIDIA AI Enterprise
- SLAs, dedicated solutions engineering, and outcome pricing
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.”
“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.”
“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.”
Ask us the question that is not on this page.
Start with one crystallizer or reactor train. Prove polymorph, yield, and reprocessing ROI in a validation-friendly pilot. Then expand across the plant.