# An open interoperability standard for closed automated cell-processing machines

Source: https://onco.cc/ideas/idea-reg-closed-manufacturing-interop-standard/  
OnCo record `idea-reg-closed-manufacturing-interop-standard` (Idea). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Each cell-therapy machine uses its own proprietary process and cartridges. A common standard would let a process run on any machine, like a document opening in any word processor.

## Summary

Closed automated systems (Miltenyi CliniMACS Prodigy, Lonza Cocoon, Cellares Cell Shuttle, Ori Biotech and others) each lock a process to one platform, so a product validated on one cannot move without a full comparability exercise. The proposal is an open standard for process description (unit operations, parameters, in-process controls, data schema) and for consumable interfaces, maintained by a standards body with regulator participation, plus a shared comparability framework so that moving a validated process between compliant platforms requires a defined, reduced data package.

## Fields

- Kind: Idea
- Last checked: 2026-09-08
- Hypothesis: Products built to the standard can be transferred between compliant platforms with a comparability package a quarter the size of today's, and the number of manufacturing sites per approved cell therapy doubles within five years.
- Rationale: Interoperability standards (DICOM in imaging, HL7 FHIR in records) unlocked competition and scale in adjacent fields. Vendor lock-in currently makes each cell-therapy process a single point of failure.
- Proposed test: Convene manufacturers, three device vendors and two regulators to publish version 1 of the standard, then demonstrate transfer of one CD19 CAR-T process between two compliant devices with side-by-side release data.
- Maturity: speculative
- Actor: engineering

## Sources

- Bottleneck evidence (Manufacturing cost and time for living and radioactive medicines): Hernandez, Prasad & Gellad, Total costs of chimeric antigen receptor T-cell immunotherapy (JAMA Oncology 2018): https://doi.org/10.1001/jamaoncol.2018.0977

## Connected records

- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/), [TIL therapy](https://onco.cc/technologies/til-therapy/)
- bottlenecks: [Manufacturing cost and time for living and radioactive medicines](https://onco.cc/bottlenecks/b-manufacturing-cell-therapy/)
- key papers: [Total Costs of Chimeric Antigen Receptor T-Cell Immunotherapy](https://onco.cc/key-papers/paper-hernandez-jama-oncol/)

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