GORE® Protein Capture Devices with Protein A
Designed to improve productivity in protein A affinity purification of monoclonal antibodies, GORE Protein Capture Devices provide high binding capacity at short residence time.
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.
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.
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 | Description | Applications |
|---|---|---|
| PROA101 | 1.0 mL Device | Drug discovery |
| PROA102 | 3.5 mL Device | Drug discovery, late stage optimization, early process development |
| PROA103 | 9.0 mL Device | Process development, clinical (GMP) applications |
| PROA201 | 58 mL Device | Clinical (GMP) applications |
| PROA202 | 116 mL Device | Clinical and Routine Manufacturing (GMP) applications |
| PROA301 | 250 mL Device | Clinical and Routine Manufacturing (GMP) applications |
| PROA302 | 500 mL Device | Clinical and Routine Manufacturing (GMP) applications |
| PROA303 | 1 L Device | Clinical and Routine Manufacturing (GMP) applications |
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 Time | 20 seconds | 30 seconds |
| Validated Cleaning Cycle Details | 0.2 N NaOH for 3 minutes up to 100 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 1 mL, 9 mL and 58 mL bind-elute curve and dynamic binding capacity 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.
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)
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
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 | |||
|---|---|---|---|
| Components | PROA101 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) | |
| Membrane support matrix | Proprietary composite | ||
| Ligand | Recombinant Protein A | ||
| Connectors | 10-32 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 Number | PROA101 | PROA102 | PROA103 | PROA201 | PROA202 | PROA301 | PROA302 | PROA303 |
|---|---|---|---|---|---|---|---|---|
| Description | 1.0 mL Device | 3.5 mL Device | 9.0 mL Device | 58 mL Device | 116 mL Device | 250mL Device | 500 mL Device | 1L 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.
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NOT INTENDED FOR USE
In medical device or food contact applications or with radiation sterilization.
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