API manufacturing director
Owns throughput, cost per kilogram, and campaign reliability. Buys yield, cycle time, and fewer failed batches.
Learn moreCustomers
The people who own the batch own this decision.
Polymorra is bought by manufacturing directors, crystallization and PAT engineers, and quality leaders — the people who carry the consequence of a failed campaign.
Built for the plants that make the world’s small molecules
- Branded pharma
- Generics
- CDMOs
- Fine chemicals
- Peptide APIs
- High-potency APIs
- Continuous plants
Who we build for
Four seats at the table
Every deployment needs manufacturing, science, quality, and IT to agree. Polymorra is designed so each of them gets what they need.
Crystallization & PAT engineer
Owns the profile and the instruments. Buys perception they cannot get from a DCS trend line.
Learn moreQA / regulatory manager
Owns release and inspection readiness. Buys audit trails, bounded autonomy, and validated model versions.
Learn morePlant IT / OT lead
Owns the network and the risk. Buys edge-first architecture, tenant isolation, and no new attack surface.
Learn moreVoices 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.”
Design partner program
What a partnership looks like
We are deliberately taking a small number of design partners so each one gets deep engineering attention. [ASPIRATIONAL — program in formation]
- Step 1
Plant review
A working session with manufacturing, science, and quality to pick the train and the metric.
- Step 2
Instrumented shadow campaign
Polymorra observes a full campaign. You get a perception layer even before any control.
- Step 3
Assist mode
Recommendations in the loop, chemist approval, and a validation package built alongside.
- Step 4
Expansion
Preferred commercial terms and roadmap influence for partners who go first.
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.
Where the value lands
What plants measure after Polymorra
4metrics we pilot against
1train to start
3autonomy levels
0rip-and-replace
Pilot metrics are agreed per site — typically polymorph consistency, yield, cycle time, and reprocessing rate. Outcome figures will be published once design-partner campaigns complete. [PLACEHOLDER]
From the field
Notes from plant reviews
What we keep hearing when we walk API trains.
“The ramp is the recipe, and the recipe is twenty years old”
Why fixed cooling profiles persist even where PAT is already installed — and what changes when supersaturation becomes a live number.
ReadTech transfer is the real bottleneck
Sites lose months re-learning a crystallization at scale. The twin is the fastest path to compressing that.
ReadQA is the buyer nobody prepares for
Every AI pitch dies in the quality review. Here is how we build for it instead of around it.
ReadTrust & 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
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.
Bring us your hardest crystallization.
Start with one crystallizer or reactor train. Prove polymorph, yield, and reprocessing ROI in a validation-friendly pilot. Then expand across the plant.