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.

Evaluate the GORE® Protein Capture Device with Protein A combined with a simulated moving bed chromatography technique, CaptureSMB(TM), to increase the productivity of IgG purification. A joint study with Athena Enzyme Systems and Gore & Associates.

Recently introduced technologies such as Protein A membrane devices and tangential flow filtration (TFF) systems capable of handling ultrafiltration and diafiltration of samples as low as 5 mL have significantly decreased the turnaround time.

This document is available upon request.

The GORE Protein Capture Device with Protein A can be used as demonstrated in three different manual/semi-automated operations to rapidly purify monoclonal antibodies without an LC unit.

Two cleaning protocols outlined in this application note potentially extend the lifetime of a GORE Protein Capture Device in the event that pressure elevates over the expected lifetime of the device.

Two 3.5 mL GORE Protein Capture Devices can be connected in series, which doubles the column capacity by providing a 7.0 mL bed volume and allows capture of at least 200 mg of monoclonal antibody within 60 minutes.

Boehringer-Ingelheim evaluated GORE Protein Capture Devices with Protein A vs. a traditional agarose bead column and found that, together with high titers, the GORE column can reduce overall process time and may help increase yields in monoclonal antibody purification by eliminating the need for additional downstream concentration steps.

Evaluate the impact of increasing operational flow rate steps (e.g. equilibrations, washes, and clean-in-place (CIP)) on the overall productivity (mg mAb/hour) of GORE Protein Capture Devices (PROA101 & PROA102).

This application note provides data to support sodium hydroxide (NaOH) exposure limits for the 1.0mL and 3.5mL GORE Protein Capture Devices (PROA101 and PROA102). The cycling protocol utilizing 0.5 molar (M) NaOH supports 50 purification cycles with minimal impact to purification yield, device capacity, or assessed purity.

Cherish Robinson, Product Specialist with Gore's PharmBIO business, discusses the advantages and disadvantages of freeze-drying bulk drug ingredients.