Overview

Affinity Chromatography slowing you down?

GORE Protein Capture Devices in 1.0 mL, 3.5 mL, 9 mL, 58 mL, 116 mL, and 232 mL sizes.

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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.*

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

 

 

 

 

 

 

 

Increase productivity: GORE Protein Capture Devices with Protein A utilize 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

Representative dynamic binding capacity of the 9.0mL GORE Device (PROA103) versus a standard agarose bead-based technology, using a purified monoclonal antibody.

GORE Protein Capture Devices are approximately 6-10x faster than traditional agarose bead-based technology which operates at typical residence times of 3–5 minutes (180–300 seconds).

Applications
Render of microsopic monocolonal antibody in blue and green

Designed for affinity purification in early drug discovery screening, late stage optimization, process development, and clinical applications for

  • monoclonal antibodies (mAbs)
  • next generation molecules that utilize the FC region for Protein A binding

The columns are compatible with standard chromatography systems.

 

Part Number Description Applications 
PROA101 1.0 mL device Drug discovery
PROA102 3.5 mL device Drug discovery
PROA103  9.0 mL device     Drug discovery, late stage optimization, process development, early GMP applications
PROA201  58 mL device Process development, clinical (GMP) applications  
PROA202  116 mL device Clinical (GMP) applications  
PROA203  232 mL device Clinical (GMP) applications  

 

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 use a unique ePTFE membrane that offers high dynamic binding capacity at short residence time. The 58 mL - 232 mL accommodate rapid cycle capability at low pressure drop, 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)
PROA102 (3.5 mL)
PROA103 (9.0mL)
PROA201 (58 mL)
PROA202 (116 mL)
PROA203 (232mL)
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 scales across sizes without compromising binding capacity or speed to quickly and effectively capture antibodies as shown in this overlay of a 1mL, 9mL and 58mL bind-elute curve.

Overlaid chromatogram showing 1.0mL, 9.0mL, and 58.0mL device UV absorbance

Overlaid chromatogram showing 1mL (blue), 9mL (red) and 58mL (green) UV absorbance . The difference in UV of harvest reflects different LC instruments.

For complete technical and product performance information, including detailed test parameters, additional yield data, purity profiles, operating conditions and more, download our data sheet.

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 58mL Device (PROA201)
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. For reference, 116 mL/min equates to 30 seconds residence time.

 

Materials of construction

 

 Components GORE PART NUMBER
PROA101 / PROA102  PROA103  PROA201 PROA202
PROA203
Device housing components Polypropylene Polypropylene and Polyether ether ketone (PEEK) primarily*
Frit material(s) Polypropylene Polyether ether ketone (PEEK) Polyvinylidene fluoride (PVDF)
Membrane support matrix Proprietary ePTFE composite
Ligand Recombinant Protein A
Connectors 10/32” threaded fittings 10-32 coned thread port 5/16-24 Flat-bottom fittings 3/4" Tri clamp (0.984" (OD))

* See datasheet or contact Gore for validation guide with additional details

Availability

GORE Protein Capture Devices are compatible with standard pre-packed column chromatography systems, and are available in 1.0 ml, 3.5mL, 9.0mL, 58mL, 116 mL and 232 mL sizes. Contact Gore for pricing and availability. Not available in all regions.

Part Number Description
PROA101 1.0 mL Device
PROA102 3.5 mL Device
PROA103 9.0 mL Device
PROA201 58 mL Device
PROA202 116 mL Device
PROA203 232 mL Device

See Validation Guides for performance specifications and evaluations.

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 PharmBIO Introduces 116mL and 232mL Protein Capture Devices with Protein A to Increase Productivity and Throughput for Antibody Purification

Posted April 5, 2022

W.L. Gore & Associates, Inc. continues to build on its growing portfolio of protein capture devices with the introduction of its new 116mL and 232mL GORE® Protein Capture Devices with Protein A. The offerings strengthen Gore’s chromatography device portfolio and follow the commercial availability of its 58mL Protein Capture Device in Q4 of 2021.

Event

Visit GORE at World ADC Europe 2022

March 29, 2022 - April 1, 2022

Visit GORE in-person or virtually at this year’s World ADC Europe. Gore is participating as an exhibition partner to showcase expertise in providing leading pharmaceutical companies with an innovative, Protein A membrane chromatography device to improve productivity in affinity purification of monoclonal antibodies. Discuss how a membrane column could be the missing single use purification link.

Event

Visit GORE at Bioprocessing Summit Europe

March 22, 2022 - March 24, 2022

Visit GORE at Bioprocessing Summit Europe 2022 March 22, 2022 - March 24, 2022 Barcelona, Spain

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.

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