Designed to improve throughput and productivity in affinity purification of monoclonal antibodies, GORE Protein Capture Devices provide high binding capacity at short residence time.
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Traditional affinity chromatography technology has not kept pace with increased titers and other upstream process improvements, leading to bottlenecks and lower productivity in downstream purification. To gain flow and shorten processing times, traditional resin-based Protein A is often over-sized or underutilized – simply to keep up.*
GORE Protein Capture Devices with Protein A utilizes a unique membrane solution that provides a binding capacity advantage at high flow rates and improves the speed of purification versus traditional technologies. Compare our Dynamic Binding Capacity (DBC) to that of agarose bead-based columns:
Dynamic binding capacity of the 9.0mL GORE Device (PROA103) versus a standard agarose bead- based technology, using a purified monoclonal antibody.
Alleviate the purification bottleneck: The new 9.0mL Device (PROA103) utilizes ePTFE membrane technology to provide performance advantages over traditional agarose resin columns in early process development.
Example dynamic binding capacity of the GORE Device (PROA101) versus a standard agarose bead- based technology, using a purified polyclonal human IgG.
Increase productivity: Gore’s 1.0mL Device (PROA101) captures greater than or equal to 30mgs/mL at 20 seconds residence time, approximately 10x faster than traditional agarose bead based technology at typical residence times.
Designed for affinity purification in early drug discovery screening, late stage optimization, and process development for
- monoclonal antibodies (mAbs)
- next generation molecules that utilize the FC region for Protein A binding
The columns are compatible with standard chromatography systems.
GORE Protein Capture Devices with immobilized Protein A* can improve throughput and yields in downstream purification by reducing overall process time. These pre-packed columns offer high dynamic binding capacity at short residence time, along with demonstrated ability to withstand multiple cleaning cycles. This increased productivity offers researchers the potential for a faster path to clinical trials.
|PROA101 (1.0mL)||PROA103 (9.0mL)|
|Dynamic binding capacity||≥ 30 mg/mL||≥ 40 mg/mL|
|Residence time||20 seconds||30 seconds|
|Number of cleaning cycles||0.2 N NaOH for 3 minutes up to 50 cycles||0.2 N NaOH for 3 minutes up to 100 cycles|
*recombinant Protein A
The GORE Protein Capture Device with Protein A quickly and effectively captures antibodies as shown in this typical bind-elute curve.
Typical chromatogram showing cycles 1, 50, and 100 overlaid for GORE Protein Capture Device (PROA103)
For complete technical and product performance information, including detailed test parameters, additional yield data, purity profiles, operating conditions and more, download our datasheet.
The GORE Protein Capture Device can streamline antibody purification processes because it incorporates a proprietary ePTFE membrane composite.
Unlike traditional support matrices, the composite membrane bed maintains a linear relationship between pressure drop and a wide range of flow rates. Because this unique structure remains stable, the membrane bed is not vulnerable to collapse, channeling or alteration of the bed.
Example pressure drop vs. flow rate relationship for the GORE Device when using phosphate buffer at room temperature.
Watch our video series: Learn more about the GORE Protein Capture Device and where this innovatove technology is headed in the future.
Materials of construction
|Components||GORE PART NUMBER|
|PROA101 / PROA102||PROA103|
|Device housing components and frits||Polypropylene|
|Membrane support matrix||Proprietary ePTFE composite|
|Ligand||Recombinant Protein A|
|Connectors||10/32” threaded fittings||10-32 coned thread port|
GORE Protein Capture Devices are compatible with standard pre-packed column chromatography systems and are available in 1.0 ml, 3.5mL and 9.0mL sizes. Contact Gore for pricing and availability. Not available in all regions.
|PROA101||1.0 mL Device||≥ 30 mg capacity|
|PROA102||3.5 mL Device||≥105 mg capacity|
|PROA103||9.0 mL Device||≥360 mg capacity|
See Validation Guides for specific capacity test parameters.
GORE Protein Capture Devices are manufactured following the applicable material quality and regulatory requirements, including relevant Good Manufacturing Processes as defined in the Gore PharmBIO quality system which is certified to ISO 13485 and ISO 15378. Contact Gore for current applicable compliance statements and quality control information.
Pharmaceutical - Protein Capture Devices - Application Note - Boehringer Ingelheim column evaluation - US
Boehringer-Ingelheim evaluated GORE Protein Capture Devices with Protein A vs. a traditional agarose bead column and found that, together with high titers, the GORE column can reduce overall process time and may help increase yields in monoclonal antibody purification by eliminating the need for additional downstream concentration steps.
Two cleaning protocols outlined in this application note potentially extend the lifetime of a GORE Protein Capture Device in the event that pressure elevates over the expected lifetime of the device.
The 9.0mL Device (PROA103) GORE Protein Capture Device provides performance advantages over traditional agarose resin columns in late stage discovery, pre-clinical and early clinical applications.
GORE Protein Capture Devices use a unique expanded polytetrafluorethylene (ePTFE) membrane composite that provides a binding capacity advantage at high flow rates to improve the speed of purification in drug discovery applications.
General handling, antibody purification protocol, troubleshooting, and ordering information.
This evaluation demonstrates a method to extend the lifetime of a GORE Protein Capture Device from 20 to 50 cycles while maintaining capacity as assessed by Dynamic Binding Capacity (DBC) at 10% breakthrough, yield, and purity.