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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.
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.*
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:
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 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.
|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|
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
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.
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)
Materials of construction
|Components||GORE PART NUMBER|
|PROA101 / PROA102||PROA103||PROA201||PROA202
|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))|
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/Ordering Information
|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:
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 Sheets, 242.9 KB
AGC Biologics and Gore Collaborate on New Protein A-based Purification Technology and Contract Manufacturing Services for Antibody Therapies
Posted December 12, 2022
AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), today announced a collaboration with W.L. Gore & Associates (Gore) that features Protein A affinity purification technology from Gore alongside the global CDMO’s contract development and manufacturing services. By using GORE and AGC Biologics, biopharmaceutical companies can improve downstream purification processes, eliminate column bioburden issues, increase product material yields in the research and development (R&D) stages, and help lower costs for clinical manufacturing.
Posted December 7, 2022
WL Gore and AGC Biologics, a leading global biopharmaceutical contract development and manufacturing organization (CDMO), recently announced a powerful collaboration. The partnership brings the GORE® Protein Capture Devices with Protein A as an integral component in the AGC Biologics’ mAb-based CDMO services. The combined offering from GORE and AGC Biologics is available across the CDMO’s global network.
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.
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.
NOT INTENDED FOR USE in medical device or food contact applications or with radiation sterilization.