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 protein A purification. To 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 protein A resin 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 a 9.0 mL 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) chromatography methods, which operate 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 through a combination of increased binding capacity and fast flow rates. These pre-packed columns use a unique ePTFE membrane that offers high dynamic binding capacity at short residence time. Designed to increase the efficiency of protein A column purification processes, the 58 mL – 232 mL Devices 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 (1.0 mL)
PROA102 (3.5 mL)
PROA103 (9.0 mL)
PROA201 (58 mL)
PROA202 (116 mL)
PROA203 (232 mL)
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

RAPID, SCALABLE PROTEIN A CHROMATOGRAPHY ELUTION

 

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 1 mL, 9 mL and 58 mL bind-elute curve.

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

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

Want complete technical and product performance information, including detailed test parameters, additional yield data, purity profiles and operating conditions?

CONTACT US        GET DATA SHEET

Technology

The GORE Protein Capture Devices with Protein A can streamline antibody purification processes because they incorporate 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 a 58 mL Device (PROA201)
Graph showing pressure drop vs. flow rate for GORE Device

Example pressure drop vs. flow rate relationship for a 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))

* For details:

GET DATA SHEET

For Validation

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Availability

GORE Protein Capture Devices are compatible with standard pre-packed column chromatography systems, and are available in 1.0 mL, 3.5 mL, 9.0 mL, 58 mL, 116 mL and 232 mL sizes. Contact Gore for pricing and availability. These Devices for protein A purification are 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. For current applicable compliance statements and quality control information:

CONTACT US

Resources

Recent News

Event

Visit GORE at CPHI Frankfurt: a 3-day event that will take place in person and online

November 1, 2022 - November 3, 2022

Join W. L. Gore & Associates for CPHI Frankfurt: a 3-day event that will take place in person and online. Join the world's leading pharma event. Where global pharma does business face-to-face.

Event

Visit GORE at BioProcess International in Boston

September 27, 2022 - September 30, 2022

Join W. L. Gore & Associates for BioProcess International, the largest BioProcessing event for learning how to accelerate promising biologics, cell & gene therapies towards commercial success.

Event

Visit GORE at BioProcessing Summit in Boston

August 15, 2022 - August 18, 2022

As one of the event sponsors, Gore invites you to join us at the Boston Sheraton, Booth # 311 — or join us online.

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.

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NOT INTENDED FOR USE in medical device or food contact applications or with radiation sterilization.