Skip to main content

Addressing the limitations of traditional Affinity Chromatography

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.

Features & Benefits
Applications

A cost-efficient platform for antibody production with comparable product quality to existing technologies and flexible for single use manufacturing.


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). Designed to enhance the efficiency of monoclonal antibody (mAb) purification processes. 

  • Enhanced Productivity: High binding capacity and fast flow rates enable rapid cycling.
  • Convenience: Pre-packed membranes are compatible with existing chromatography systems.
  • Consistent Scalable Performance: Designed for scalability without compromising capacity, pressure, or elution widths across sizes from 1mL to 1L.
  • Cost Efficiency: Improved productivity and reduced Protein A usage contribute to lower batch costs.
  • Risk Reduction: Flexible for single-use processing eliminating the need for repeated handling of resin columns and risk for contamination

Representative dynamic binding capacity demonstrated with a 9 mL GORE Device (PROA103) versus a standard agarose bead-based technology, using a purified monoclonal antibody.

Image
protein A dynamic binding capacity

Affinity Chromatography Applications

Designed for affinity purification across all stages of drug development, these systems support early discovery screening, late-stage optimization, process development, clinical trials, and routine bioprocessing for monoclonal antibodies (mAbs) as well as next-generation molecules that utilize the Fc region for Protein A binding.

The columns are compatible with standard chromatography systems.

Part Number DescriptionApplications
PROA1011.0 mL DeviceDrug discovery
PROA1023.5 mL DeviceDrug discovery, late stage optimization, early process development
PROA1039.0 mL DeviceProcess development, clinical (GMP) applications
PROA20158 mL DeviceClinical (GMP) applications
PROA202116 mL DeviceClinical and Routine Manufacturing (GMP) applications
PROA301250 mL DeviceClinical and Routine Manufacturing (GMP) applications
PROA302500 mL DeviceClinical and Routine Manufacturing (GMP) applications
PROA3031 L DeviceClinical and Routine Manufacturing (GMP) applications
Image
Monoclonal antibody pharmaceutical
Learn About Our Protein Membrane Employed in a Single-Use Platform

Technical Specifications

GORE Protein Capture Devices with immobilized Protein A* are designed to enhance downstream purification by improving productivity. These pre-packed columns feature a unique membrane that delivers high dynamic binding capacity with short residence times. Designed to increase the efficiency of protein A column purification processes, the 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.

 Binding Capacity and Cycling Information
Dynamic binding capacity≥ 30 mg/mL≥ 40 mg/mL 
Residence Time20 seconds30 seconds
Validated Cleaning Cycle Details0.2 N NaOH for 3 minutes up to 100 cycles0.2 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 1 mL, 9 mL and 58 mL bind-elute curve and dynamic binding capacity graph.

Image
gore protein capture bind elute curve graph

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.

Image
overlaid DBC10 comparison chart 1

Overlaid DBC10% comparison of 58 mL (red) and 250 mL (blue).

The GORE Protein Capture Devices with Protein A can streamline antibody purification processes because they incorporate a proprietary membrane composite. Unlike traditional support matrices, the composite membrane bed maintains stable performance across a wide range of flow rates, avoiding collapse, channeling, or structural changes.

Pressure Drop 
for a 58 mL Device (PROA201)

Image
affinity chromatography pressure versus flow rate

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.

Pressure Drop
Consistency

Image
affinity chromatography pressure drop consistency

Example of pressure drop vs. residence time consistency for the 58 mL (blue), 250 mL (red) and 500 mL (grey) when using phosphate buffer at room temperature.

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.

 Gore Part Number
ComponentsPROA101
PROA102
PROA103
PROA201
PROA301
PROA202
PROA302
PROA303
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 composite

Ligand

Recombinant Protein A

Connectors10-32 threaded fittings (PROA101/PROA102)5/16-24 Flat-bottom fittings (PROA201)3/4" Tri clamp (0.984" (OD))
10-32 coned thread port (PROA103)1/2-20 flat-bottom threaded fittings (PROA301) 

GORE Protein Capture Devices are compatible with standard chromatography systems, and are available in sizes as listed in table below. Contact Gore for pricing and availability. These Devices for protein A purification are not available in all regions.

Part Number/Ordering Information

Part NumberPROA101PROA102PROA103PROA201PROA202PROA301PROA302PROA303
Description1.0 mL Device3.5 mL Device9.0 mL Device58 mL Device116 mL Device250mL Device500 mL Device1L Device

See Validation Guides for performance specifications and evaluations

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.

Explore More

NOT INTENDED FOR USE

In medical device or food contact applications or with radiation sterilization.

Prefer to Call?

Have questions or unique requirements? 
Our experts are here to guide you.

+1 410 476 2699