Overview

Affinity Chromatography slowing you down?

GORE Protein Capture Devices in 1.0 mL, 3.5 mL, 9 mL, and 58 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  

 

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 58mL accommodates 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)
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
Device housing components Polypropylene Polypropylene
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

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, and 58mL 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

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 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.

Featured Story

Shaping the Future of Medicine

Posted February 2, 2017

Picture a future where advanced cancer is considered more of a chronic illness than a life-threatening one. Where potentially debilitating autoimmune conditions can be stopped at their source. And where patients with progressive neurological diseases have new hope for long, healthy lives.

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