GORE® Protein Capture Devices with Protein A
Designed to improve productivity in affinity purification of monoclonal antibodies, GORE Protein Capture Devices provide high binding capacity at short residence time.
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Resource Library
Application Note: Extending the Lifetime of GORE® Protein Capture Devices through Alternative Cycling Parameters
Technical Information, 147.61 KB
This evaluation demonstrates a method to extend the lifetime of a GORE Protein Capture Device from 20 to 50 cycles while maintaining capacity as assessed by Dynamic Binding Capacity (DBC) at 10% breakthrough, yield, and purity.
English (U.S.)
All Resources For GORE® Protein Capture Devices with Protein A
- Technical Information (12)
- Data Sheets (3)
- Validation Guides (3)
- Brochures (1)
Overview
GORE Protein Capture Devices in 1.0 mL, 3.5 mL, 9 mL, and 58 mL sizes.
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:
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
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 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)
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/Ordering Information
| 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
Application Note: Cleaning Protocols to Reduce Effects of Pressure Rise Over the Lifetime of a GORE® Protein Capture Devices
Technical Information, 471.19 KB
Data Sheet: GORE Protein Capture Device for Early Clinical Applications, 9.0mL (PROA103)
Data Sheets, 242.9 KB
Data Sheet: GORE® Protein Capture Devices
Data Sheets, 233.05 KB
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.
Visit Gore at PepTalk 2020 in San Diego, CA USA January 20-24 at Stand 423 at the Hilton San Diego Bayfront
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.
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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