NO MORE PROTEIN AGGREGATIONIN TFF

LEVITRONIX® PUMP SYSTEMS

DON’T LET A PUMP DAMAGE YOUR PRODUCT

Tangential Flow Filtration (TFF) is a crucial step in biopharmaceutical manufacturing that requires the highest possible protein yield. Conventional pump systems such as peristaltic or 4-piston diaphragm pumps cause protein degradation due to mechanically induced shear of valves and tube compression. Furthermore, such systems generate a pulsating flow, resulting in non-optimal filter performance and reduced flux. Levitronix® pump systems are designed for demanding TFF applications where ultra low shear as well as a pulsation free and continuously controlled flow ensure the highest protein yield.

ADVANTAGES OF A LEVITRONIX® PUMP SYSTEM

The very large gap between the rotor and pump housing guarantees that no protein is being damaged or trapped.

Pres

sure

[bar

]

2.752.702.652.602.552.502.452.402.352.302.25

Time [h]0.00 0.20 0.40 0.60 0.80

Pulsation of a Levitronix® pump system in comparison to a 4-piston diaphragm pump at 20 lpm and 2.5 bar.

Levitronix® PuraLev® 600SU

4-piston diaphragm pump

The magnetic levitation technology guarantees that no pump components come in contact with one another enabling a continuous and smooth flow.Additionally, the pump design ensures that no protein is trapped or damaged by valve interaction or tube compression, eliminating virtually all shear.

Magnetic Field Line

Lowest Shear // highest protein yield

Pulsation Free Flow // constant transmembrane pressure (TMP) - optimal flux at minimal gel layer formationLevitronix® pump systems deliver a pulsation free flow, independent of actual flow or pressure. With optional pressure or flow sensors, the Levitronix® control unit will keep the pressure / TMP or flux constant, independent of fluid or filter properties.

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LOWEST PARTICLE SHEDDING

A PuraLev® 600 in comparison to a peristaltic pump of a similar hydraulic characteristics.

Levitronix® pumps have the highest turn down ratio by being able to control and maintain the flow from a few ml/min up to the maximum flow rate.

Highest Turn Down Ratio // high concentrations achievable with one pump size

Intrinsically Safe //keep your product and personnel safe - no more pressure build-up or tube ruptures Set and limit the maximum pressure according to your tubing specifications and you will be assured that your media is safe no matter what occurs in your hydraulic flow path.

Lowest Particle Shedding //the cleanest pump system – beyond biopharmaTFF processes are generally at the end of the down stream process and any particle addition risks the purity of the final product. Due to the low shear factor plus no wear or mechanical contact between moving parts such as membranes or tubings, particle generation is eliminated. Levitronix® is the cleanest pump system and meets the purity demand of not only biopharma processes but also industries with much higher purity requirements such as semiconductor production.

Small Footprint, Low Noise Generation //save valuable spaceAll Levitronix® pump systems have a much smaller footprint than competitive pumps of comparable hydraulic performance. The constant flow of these systems also eliminates any noise generation from your process.

182

mm

305

mm

166.7mm

442 mm

150 mm

280 mm

Cumulative particle size distributions at 16 lpm and 2.5 bar

Cum

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ive

Con

cent

ratio

n [#

/ml]

Particle Diameter [µm]

10-3

10-2

10-1

100

101

1.00 10.00

Levitronix®

Peristaltic Pump4-piston Diaphragm PumpBackground

10-4DL

LCO-600

LCO-2000

LCO-i100

Levitronix Console Easy Controllability of TMP and FlowAutomated TFF processes require many different parts such as a pump in conjunction with multiple sensors, an external control unit and a user interface that con-nects all devices. The assembly of the loop from single components is typically complex, however complete packages are usually standardized and do not allow individual process adaption. This can lead to an unsatis-fying process solution. The Levitronix® LCO series deliver all-in-one control of the pump, sensors and complete process with a single

intuitive control unit. This plug and play solution allows configuration of all process relevant parameters with the 7” touch panel display.Every control unit has an integrated PI controller. Just connect your sensor and run the system in closed loop feedback control at your desired process set point. The console has multiple flow and pressure sensors inlets, allowing easy and accurate control of flow, pressure or even TMP.

FactsShear stress in pumps causes protein aggregation, resulting in reduced yield.

Test conditionsLysozyme solution was pumped into two identical closed loops by different pump technologies. Flow was set at 10 and 20 lpm with back pressures from 0 to 2.5 bar.

Results• No protein aggregation was observed with the

Levitronix® pump.• Protein aggregation consistently increased when

using the 4-piston diaphragm pump.• Enzyme activity remained at 100% while using the

Levitronix® pump compared to a total loss of enzyme activity when the 4-piston diaphragm pump was used for an extended time.

• Consistent results were achieved throughout all working conditions.

• Additional results on request.

No Protein Aggregationwith Levitronix®

Protein Aggregationwith Diaphragm Pump

Activity PuraLev® 600SUActivity 4-piston diaphragm pumpParticle size PuraLev® 600SUParticle size 4-piston diaphragm pump

Rela

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activ

ity [%

]

140

120

100

80

60

40

20

0

7

6

5

4

3

2

1

0

Parti

cle

size

[µm

]

0.00 16.67 33.33 50.00 66.67 83.33 100.00 116.67 133.33 Time [h]

Rela

tive

activ

ity [%

]

140

120

100

80

60

40

20

0

7

6

5

4

3

2

1

0

Parti

cle

size

[µm

]

0.00 16.67 33.33 50.00 66.67 83.33 100.00 116.67 133.33 Time [h]

Rela

tive

activ

ity [%

]

140

120

100

80

60

40

20

0

7

6

5

4

3

2

1

0

Parti

cle

size

[µm

]

0.00 16.67 33.33 50.00 66.67 83.33 100.00 116.67 133.33 Time [h]

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PROTEIN STUDY RESULTSHigh protein activity - small particle size

Relative activity at 20 lpm and 2.5 bar

Relative activity at 10 lpm and 2.5 bar

Relative activity at 10 lpm and 1.5 bar

Highest Protein Yield // Levitronix in comparison to 4-piston diaphragm pump

Overview // SU Pump Systems

PuraLev® i30SU

1.0 bar (14.5 psi)7.7 l/min (2.0 gpm)

PuraLev® 200SU

2.0 bar (29 psi)21 l/min (5.5 gpm)

PuraLev® 600SU

3.1 bar (45 psi)75 l/min (20 gpm)

PuraLev® 2000SU

4.3 bar (62.4 psi)140 l/min (37 gpm)

2.0 bar (29 psi)17 l/min (4.5 gpm)

PuraLev® i100SU

Levitronix GmbHTechnoparkstr. 1CH-8005 ZurichSwitzerland Phone +41 44 445 19 13Fax +41 44 445 19 14E-Mail salesEurope@levitronix.com

Headquarter and European Contact

Levitronix Technologies Inc.20 Speen Street, Suite 102FraminghamMassachusetts 01701 USA

Phone +1 508 861 3800Fax +1 508 861 3837E-Mail salesUS@levitronix.com

US Contact

Levitronix Japan K.K.Wing Eight 5floor, 4-16-4Asakusabashi, Taito-kuTokyo, 111-0053 Japan

Phone +81 3 5823 4193Fax +81 3 5823 4195E-Mail salesJapan@levitronix.com

Japan Contact

Levitronix TaiwanRm. 3, 8F., No.38, Taiyuan St.Zhubei City, Hsinchu County 302Taiwan (R.O.C)

Phone +886 3 5600178Mobil +886 988 321472E-Mail salesAsia@levitronix.com

Taiwan Contact

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Mass density = 1 g/cm3

Viscosity = 0.7 cPLiquid Temp.: 40ºC

0 3010 20

[liters/min]

0 25 50 75 100 125 150

[gallons/min]

5.0

4.0

3.0

2.0

1.0

0.0

[bar]

[psi]

60

40

20

0

PuraLev® i30SU

PuraLev® i100SU

PuraLev® 200SU

PuraLev® 600SU

PuraLev® 2000SU

5 15 25 35

Max. Pressure

Max. Flow