GORE® Protein Capture Devices with Protein A

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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Application Note:  Extending the Lifetime of GORE® Protein Capture Devices

Chromatography

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.

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All Resources For GORE® Protein Capture Devices with Protein A

Overview

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.*

*Reference: “Disrupting Downstream Process Bottlenecks.” Genetic Engineering, June 14, 2018.

 

 

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:

 

Graph of binding capacity of GORE Device (PROA103) vs standard technology

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.

 

Graph of binding capacity of GORE Device (PROA101) vs standard technology

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.

 

Applications
Render of microsopic monocolonal antibody in blue and green

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.

 

Performance

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.

Bind-Elute Curve for 9.0mL Device (PROA103)
Graph showing bind-elute curve for 9.0mL Device (PROA103)

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.

Technology

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.

Performance under pressure
Pressure Drop for 9.0mL Device (PROA103)
Graph showing pressure drop vs. flow rate for GORE Device

Example pressure drop vs. flow rate relationship for the GORE Device when using phosphate buffer at room temperature.

 

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

Availability

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.

Part Number Description Capacity
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.

Regulatory Compliance and Quality

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.

Resources

Recent News

Press Release

Gore introduces new 9.0mL Protein Capture Device for affinity chromatography

Posted March 20, 2020

Gore is adding to it's range of affinity chromatography devices with the larger 9.0 mL size device for applications in process development, pre-clinical and early clinical drug development. This launch is significant because it demonstrates that this innovative membrane technology can be scaled to larger sizes without losing performance benefits.

Event

Gore at PepTalk 2020

January 20, 2020 - January 24, 2020

Visit Gore at PepTalk 2020 in San Diego, CA USA January 20-24 at Stand 423 at the Hilton San Diego Bayfront

Press Release

GORE™ Protein Capture Device Drives Timeline Reduction for CRO

Posted May 2, 2017

Aragen Bioscience Inc. will be presenting a poster titled “A Platform to Rapidly Purify and Formulate Immunoglobulins from Mammalian Expression Systems” at the 13th Annual Pro-tein Engineering Summit (PEGS). The platform features the new GORE™ Protein Capture De-vice with Protein A for rapid mAb purification, as well as other technologies.

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