An open interoperability standard for closed automated cell-processing machines
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.
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.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.