Xcellerex XDR-10 Bioreactor System, Single Vessel

Power number depends on the impeller design and its configuration, for our XDR’s please see table below.

Scale up is important for drug substance manufacturing, to meet the expected demand; the process is not going to be produced using shaker flask but actually large systems. Process development scientist have to assess scalability from 2 angles, engineering factors (agitation, head space, pressure, air flow) and molecular biology (media optimization, cell line development and cell bank generation) all these factors play a role in scale up.

A good practice is to scale up based on P/V (Power/Volume) where its limited in the 2000L to 32 W/m^3, another method especially for shear sensitive cells is interfacial shear velocity of below 15 1/sec. For more additional support our BMS group has extensive experience in scale up.

Yes, the XDR’s have been used in perfusion processes ranging from XDR-50 to XDR-2000. The Wonderware software can support automated media addition and continuous harvest.

The bag has multiple layers to ensure strength, flexibility. As for the product contact material it is ULDPE (Ultra Low Density Poly Ethylene).

Shear force is dependent on the impeller diameter, agitation speed and liquid density. So its multi factor dependent even media composition can affect the value. However, our XDR’s have high mixing efficiency yet, low shear rate between all scales. It is recommended to keep the shear rate below 15 1/s. The calculation to determine the value is below.

Np= Power number      ρ = liquid density
d= Impeller diameter   D= Tank diameter
N= Agitation per second    

The XDR-50 TO 1000 have poly propylene material, and the XDR-2000 has a PEEK material (Poly Ethyl Ether Ketone).

We have multiple size options, depending on the cell line and how sensitive is it to shear. The sizes are (microsparging) 2 micron, 20 micon, and( macrosparging) 0.5 mm, and 1.0 mm drill hole.

The software searches for different tags based on time/date stamps, the tags include pH, temperature, Dissolved oxygen …etc. To actually give batch identification number a special license in required from Wonderware.

kLa is the mass transfer coefficient, that dictates how well is the oxygen being transferred from the sparger to the cells. We measure it using the gassing out method using nitrogen and gas. The value depends on multiple factors such as working volume, air flow and agitation. A complete mapping study is currently being tested and will be published once complete.