Your operation was never 4 systems.
Frontier Manufacturing Intelligence. One system.
End-to-end agentic manufacturing, unleashed.
Designed to support
- GxP21 CFR Part 11 · EU Annex 11
- SOC 2Security · availability · confidentiality
- HIPAAPHI stays with the site of care
Today
One patient. Nine systems. One month.
Cell & Gene Therapy has shown immense promise as the new frontier of medicine, but its supply chain remains expensive and complex due to system fragmentation. Click through the patient journey to understand the current state.
We use an autologous therapy as the example because it strains the status quo hardest: systems built for a different scale of lot, configured at length to handle a lot of one. Cellpath runs autologous and allogeneic alike.
Vein to vein · about a month
Enrollment & Scheduling
The site of care coordinates with the clinical operations team to enroll the patient and select a timeslot to manufacture their dose. The patient's identity is created here, then re-keyed at every step that follows.
Systems involved
- Orchestration platform
- Electronic data capture
- Electronic health record
1 of 3 consolidated by Cellpath.
eSystems across the nine steps
Nine systems, and the patient's identity re-keyed at every handoff.
Each handoff is an integration project, a reconciliation, and a place to lose the patient.
With Cellpath
Collapse multiple systems into one unified platform, autologous or allogeneic. Chain of identity exists once. The clinic keeps its chart.
With Cellpath
Introducing Cella, the first agentic harness for manufacturing, integrated with Cellpath out of the box.
Complexity distilled into an AI that does useful work.
One ontology
Batch record in MES. BOM in ERP. CoA in LIMS. Checklist in EQMS. Four systems reconciled by hand before a lot ships. In Cellpath it's one lot, already reconciled. Disposition in minutes.
One loop
Cella reads, proposes, executes, records. Every tool call passes one gate.
One trail
No signature without proof of reading. No action without a record.
Human-in-the-loop by design. Every signature is gated on a SHA-256 proof-of-reading token. Every action lands in an append-only, tamper-evident audit trail. Built for 21 CFR Part 11 and EU Annex 11.
Prevention
Deviations are prevented, not logged.
In a fragmented stack the specification is a PDF, the batch record is a form, and the check happens at review, after the fact. Cellpath binds the spec to the record, and the record to every execution. The limit is enforced when the value is entered.
Spec document
Specification, master batch record, SOP.
Controlled, versioned, effective-dated. The document people review and approve.
Electronic record
The same document, as data.
Parameters, limits, materials, methods, roles, and equipment, tied to the recipe version the spec approved.
Execution
Every step runs against the record.
Guardrails enforce limits, materials, qualifications, and calibration at the point of entry. Anything out of range or out of spec is caught the moment it happens, and the exception opens on that step.
Real-world deviations still happen. When they do, they are raised on the batch step where they occurred, already linked to the lot, the material, and the test they touch.
Inside the ontology
The map is the database.
An ontology is the map of what exists and how it relates: product, recipe, batch, material lot, sample, result, patient. In Cellpath that map is not documentation. It is the database, and a question that took a week of reconciliation is one click.
Click to pause · drag to rotate
Cost. Speed. Decision intelligence.
One platform where four used to run, and no integrators wiring them together. Our aim: cut software and services spend by up to 80% for early-stage clinical programs.
Cost
Four licenses. The glue makes five. Cellpath makes one. Every prevented deviation is an investigation you do not run.
Speed
Disposition in minutes. Batch record, bill of materials, results, and checklist are one lot, already reconciled. No nightly sync.
Decision intelligence
From what happened to what to do next. A deviation knows its impact. A change control arrives drafted. People decide; they stop searching.
Nothing to integrate.
One system. One agent. Tell us what you would put on it.