iDEM Technology. Closed, automated cell expansion and differentiation.
CoatingAuto
SeedingAuto
FeedingAuto
ImagingAuto
PassagingAuto
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Avoid the 3D comparability detour with iDEM's 2D culture automation.
Rapidly translate any 2D process from manual to automated.
Banking iPSC Expansion Pluripotent stem cells expanded from one vial to a hundred-vial bank.
Differentiation Neural Progenitor Cells Neural progenitor cells (DANPCs) used to treat diseases such as Parkinson’s
Differentiation Cardiomyocytes iPSC-derived cardiomyocytes to treat chronic heart failure
Differentiation Retinal Pigment Epithelium RPE cells used to treat macular degeneration and reverse vision loss
Rapidly scale the quality of your best scientists.
10× Faster production ramp up No hiring & training bottlenecks
10× Less operator-hours per batch
10× Batches per Cleanroom
2.16 m² Growth area access up to 24 patient batches per device
MytosOS. Turn your best practices into repeatable operations at scale.
Rapid Translation Ports any 2D process within 3 runs.
Real-Time Monitor Tracks batches and flags potential out-of-specifications.
Every layer of iDEM is GMP-ready.
Mytos Cloud
21CFR Part 11 ready
Integrated environmental monitoringConfigurable operator e-signatures / alertingAutomated feature validation for GMP environmentsAuto-generated Batch Records
21CFR Part 11 ready
Integrated environmental monitoringConfigurable operator e-signatures / alertingAutomated feature validation for GMP environmentsAuto-generated Batch Records
CE markedSuitable for use in ISO 7 cleanroomManufactured in the UK under ISO 9001IOQ & regulatory support packages available
Validated sterile single-use consumablesUSP Class VI & USP788 compliantPyrogen & animal-origin free fluid pathCleanroom assembled in the USA under ISO 13485CoC & regulatory support data packages available
Manufacture with Mytos.
Frequently asked questions
The iDEM system is designed & manufactured under a QMS to meet the requirements of GMP Manufacturing. IOQ & regulatory support packages available.
Yes. MytosOS provides configurable operator sign offs/alerting, electronic batch records, deviation management, and is ALCOA+ compliant — all purpose-built for GMP cell therapy manufacturing.
GMP-grade consumables are currently available for early access partners. General availability is planned for Q3 2026.
Yes. Mytos provides full IQ/OQ and support your team with PQ. Full validation support is also available.
Mytos supports clinical & commercial partners through provision of DMFs, risk assessments, and change control documentation. Our regulatory team supports FDA, EMA, and MHRA submissions.