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BioSep: - sonosep

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The <strong>BioSep</strong> features<br />

• Cell filtration by ultrasonic<br />

resonance field<br />

• Continuous operation<br />

• Low shear environment<br />

• Simple design<br />

• Compact autoclavable<br />

device<br />

• Compact In-Situ-<br />

Sterilizable device<br />

• Scalable system<br />

The <strong>BioSep</strong> advantages<br />

• No physical filter surfaces<br />

to foul<br />

• No mechanical parts to fail<br />

(no moving parts)<br />

• Small retention volume<br />

• Rapid turn around<br />

(low hold-up times)<br />

• Increased efficiency<br />

• Wide flow range<br />

• High cell viability<br />

• Consistent culture<br />

environment<br />

• Easy installation<br />

• Easy automation<br />

• Minimal operator<br />

involvement<br />

• Clean-In-Place<br />

The main production systems which are used today for Mab production are stirred tanks.<br />

Homogeneous systems like a stirred tank represent the biggest unit reactor volume<br />

attainable today and with the highest unit production capacities. This capacity can be<br />

increased drastically with the use of a cell retention device.<br />

The <strong>BioSep</strong> will typically remove between 90 and 99% of the cells in the harvest stream at<br />

a reactor cell concentration of up to 20 million cells/ml. The separation efficiency of the<br />

<strong>BioSep</strong> system is defined as:<br />

( )<br />

SE = 100 % 1 – Ch<br />

Cb<br />

• SE is the separation efficiency<br />

• Ch is the cell concentration in the harvest<br />

• Cb is the cell concentration in the bioreactor<br />

The separation efficiency of the <strong>BioSep</strong> system (10L, 50L and 200L) is controlled<br />

by adjusting the acoustic power input to the resonator and the run/stop cycle time ratio<br />

for the <strong>BioSep</strong> and harvest pump.<br />

Pump control cable<br />

Compressed air<br />

Output<br />

cable<br />

Harvest<br />

Recirculation pump<br />

Feed<br />

Effects on the economics of an acoustic perfused process as compared<br />

to a batch process:<br />

• improved efficiency in medium use (e.g. lower serum concentrations in growth medium),<br />

up to 5 times more efficient. The trapped and returned cells use only nutrients to maintain<br />

their metabolism and for biosynthesis of products.<br />

• a factor 10-20 higher viable cell concentration<br />

• antibody production per reactor volume per day with a factor 10-100 fold higher than<br />

in a batch (high volumetric productivity).<br />

• better on-line control due to steady state condition<br />

• reduced exposure of the products to proteases<br />

• antibody concentration in harvest improved with a factor 2-5 fold compared to batch process<br />

• downstream processing of the secreted product is reduced by one step.

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