iCELLis™ single-use, fixed-bed bioreactor systems

The iCELLis™ bioreactor system is an automated, single-use, fixed-bed bioreactor that provides controlled cell growth conditions for adherent cells. Available in three formats, they deliver scalable performance from 0.5 to 500 m², supporting process development through clinical and commercial production of gene therapies, vaccines, and other products. These systems simplify and intensify processes from low-density seed train to final product, enabling faster achievement of clinical milestones and market entry.

These features include:

Productivity and scalability

• A compact, closed, high-cell-density fixed-bed, resulting in high productivity and streamlined operations
• Predictable scalability from bench-top (0.5 m²) to large-scale manufacturing (500 m²)
• Significant decrease in operational costs and capital investments compared to classical 2D flatware due to simplified handling and reduced footprint

Cell culture environment

• Optimized media falling film (aka “waterfall”) that provides high levels of oxygenation with low shear
• A fixed-bed acting as natural cell retention device, enabling media perfusion or recirculation and low shear mixing

Automation and integration

• Advanced automation systems for efficient and robust maintenance of cell culture critical parameters; 21 CFR Part 11 compliant software
• Fully integrated, single-use sensors for pH, dissolved oxygen (DO), pressure, and biomass, reusable temperature sensor through a thermowell
• A set of tubing assemblies, compatible with tube welding and aseptic connectors, specifically designed to perform key bioreactor operations

System formats

System	iCELLis Nano bioreactor	iCELLis 50 bioreactor	iCELLis 500+ bioreactor
Components	Docking station mPath control tower iCELLis Nano bioreactor vessel Tubing manifolds mPath Link server	Docking station Integrated mPath control tower iCELLis 50 bioreactor vessel Tubing manifolds mPath Link server	Integrated skid with docking station and control tower Temperature control unit (TCU) iCELLis 500+ bioreactor vessel Tubing manifolds
Surface area range	0.5 to 4 m2	6.6 to 50 m2	66 to 500 m2
Sensors	pH, DO, temperature, and biomass	pH, DO, temperature, biomass, weight, and pressure	pH, DO, temperature, biomass, weight, and pressure
21 CFR Part 11 compatible software	Suitable for the manufacture of small batches in a GMP environment	Bioreactor can be easily used to manufacture in a GMP environment	Bioreactor can be easily used to manufacture in a GMP environment
Fill and drain time	< 1 min	< 40 min	< 20 min
Control tower and supervisory control and data acquisition	mPath Link tower + mPath Link network	Integrated or network mPath Link	AVEVA ArchestrA (integrated with equipment)