the intelligent membrane filtration system - GE Healthcare Life ...
the intelligent membrane filtration system - GE Healthcare Life ...
the intelligent membrane filtration system - GE Healthcare Life ...
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ÄKTAcrossflow – <strong>the</strong> <strong>intelligent</strong><br />
<strong>membrane</strong> <strong>filtration</strong> <strong>system</strong><br />
ÄKTAcrossflow is a fully automated<br />
<strong>filtration</strong> <strong>system</strong> for cross flow <strong>membrane</strong><br />
screening and process development.<br />
It is also <strong>the</strong> first <strong>system</strong> to enable<br />
automation at small-scale, with capacity<br />
ranging from liters down to 25 ml,<br />
making it useful for research and protein<br />
preparation. The compact design fits<br />
neatly onto a bench top and <strong>the</strong> <strong>system</strong><br />
works with a broad range of applications<br />
from micro<strong>filtration</strong> to ultra<strong>filtration</strong>.<br />
ÄKTAcrossflow, developed toge<strong>the</strong>r with a biopharmaceutical<br />
manufacturer, is <strong>the</strong> latest member of <strong>the</strong> ÄKTAdesign family,<br />
and extends <strong>the</strong> UNICORN controlled platform into <strong>membrane</strong><br />
<strong>filtration</strong>. The <strong>system</strong> comprises a separation unit built with<br />
ÄKTAdesign components for reliability, flexibility and scalability.<br />
UV, pH and conductivity detectors as well as air, pressure, and<br />
temperature sensors are all part of <strong>the</strong> unit. Electronically<br />
actuated diaphragm valves reduce hold-up volumes and prevent<br />
dead volumes. The compact, space-saving, bench top <strong>system</strong><br />
is ideal for a broad range of applications, and has <strong>the</strong> ability to<br />
operate ei<strong>the</strong>r hollow fiber cartridges or cassettes.<br />
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Fast, secure and automated<br />
The UNICORN control software monitors and captures sensor data<br />
and real-time parameter trends; while method wizards provide<br />
easy method generation. This combination of control during cross<br />
flow processing and <strong>the</strong> automatic handling and evaluation of<br />
data ensures complete mastery of cross flow processes.<br />
One of <strong>the</strong> benefits of working with ÄKTAcrossflow is <strong>the</strong> significant<br />
amount of time that can be saved during process development.<br />
Results are delivered by UNICORN in just a few hours compared<br />
to weeks when working with manual <strong>system</strong>s, while human error<br />
is eliminated from <strong>the</strong> task of transferring data to spreadsheets.<br />
Moreover, UNICORN allows efficient data evaluation and<br />
provides full tracking and documentation of processes (Fig 1).<br />
UNICORN complies fully with all applicable regulations, including<br />
21 CFR Part 11.
Protects sample<br />
ÄKTAcrossflow offers <strong>the</strong> highest level of protection for your<br />
sample. The <strong>system</strong> has three high precision metering pumps<br />
that operate over <strong>the</strong> entire flow/viscosity range without <strong>the</strong> need<br />
for flowmeters. The verified pump design minimizes shear forces,<br />
ensuring that sensitive cellular material is not damaged. Moreover,<br />
heat transfer from <strong>the</strong> pump heads to <strong>the</strong> process fluid is so low<br />
that cooling is unnecessary. The feed pump features four pump<br />
heads for gentle and pulsation-free circulation of sensitive process<br />
fluids at rates up to 600 ml/min. The transfer and permeate pumps<br />
allow for 200 ml/min pulsation-free flow.<br />
Sanitary design<br />
The pump heads have a sanitary design with a self-contained<br />
rinsing <strong>system</strong> to prevent contamination and pump damage.<br />
Valve units are also sanitarily designed, with EPDM <strong>membrane</strong>s for<br />
high chemical resistance. The valve blocks include multiple valves<br />
to minimize hold up volumes. The <strong>system</strong> is effectively sanitized<br />
with 1 M sodium hydroxide (NaOH) which has demonstrated<br />
high efficiency in microbial challenge tests, fulfilling <strong>the</strong> USP 27<br />
requirements of log 6 reduction of colony forming units.<br />
A more efficient way of working<br />
The ÄKTAcrossflow <strong>system</strong> with UNICORN control supports <strong>the</strong><br />
process control modes commonly used in ultra<strong>filtration</strong> and<br />
micro<strong>filtration</strong> applications such as TMP control and flux control<br />
(Fig 2). These control modes can be combined with selectable feed<br />
pump instructions, such as feed flow rate, feed pressure, Delta P,<br />
retentate flow rate or shear rate. UNICORN also reports real-time<br />
process parameters such as retentate volume, concentration factor,<br />
dia<strong>filtration</strong> exchange factor, and accumulated permeate volume.<br />
The networking capabilities with UNICORN/OPC allow for flexibility in<br />
process design and total process control. As <strong>the</strong> cross flow process<br />
is scaled up, <strong>the</strong> ÄKTAcrossflow <strong>system</strong> can communicate with <strong>the</strong><br />
UNICORN controlled manufacturing cross flow skid, just as <strong>the</strong><br />
ÄKTApilot <strong>system</strong> can communicate with <strong>the</strong> BioProcess skid.<br />
UNICORN links <strong>the</strong> unit operations to create one fluid process.<br />
ÄKTAcrossflow uniting processes<br />
<strong>GE</strong> <strong>Healthcare</strong>’s long experience and expertise in automated<br />
chromatography procedures can now be transferred to cross flow<br />
<strong>filtration</strong> to provide an integrated process solution with <strong>the</strong> familiar<br />
and proven UNICORN platform. Figure 3 shows an integrated<br />
process for plasmid purification combining ÄKTAcrossflow and<br />
ÄKTAexplorer <strong>system</strong>s.<br />
In summary<br />
ÄKTAcrossflow is providing a small revolution in <strong>filtration</strong>. By<br />
building UNICORN into <strong>the</strong> <strong>system</strong>, <strong>filtration</strong> processes can now<br />
be automated allowing <strong>the</strong> operator to be in full control of <strong>the</strong><br />
process, and get results in a matter of hours.<br />
Fig 1. UNICORN fulfills stringent control and data<br />
handling procedures.<br />
Fig 2. Raw data recorded from process optimization for<br />
BSA concentration/dia<strong>filtration</strong> using TMP scouting with<br />
100g/l and 20g/l BSA solutions.<br />
Fig 3. An integrated plasmid purification workflow<br />
using ÄKTAcrossflow and ÄKTAexplorer. For process<br />
development, <strong>the</strong> PlasmidSelect process can purify over<br />
100 mg of plasmid DNA in a single run on ÄKTAcrossflow<br />
and ÄKTAexplorer <strong>system</strong>s. For production scales, an<br />
integrated process using UniFlux and ÄKTAprocess <br />
<strong>system</strong>s can provide several kilograms of supercoiled<br />
plasmid DNA.<br />
Fur<strong>the</strong>r information<br />
Data File<br />
ÄKTAcrossflow automated cross flow <strong>filtration</strong><br />
for process development, Code No. 11-0032-71<br />
Brochure<br />
ÄKTAcrossflow Putting <strong>the</strong> ”brain” into<br />
<strong>membrane</strong> screening, Code No. 11-0034-87<br />
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