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General handling, antibody purification protocol and troubleshooting guide for PROA103.

General handling, antibody purification protocol, troubleshooting, and ordering information.

General handling, antibody purification protocol and troubleshooting guide for 58mL (PROA201), 116 mL (PROA202), 232 mL (PROA203), 250 mL (PROA301), 500 mL (PROA302), and 1L (PROA303).

During the manufacturing process, therapeutic antibodies are exposed to a range of hydrodynamic forces and material contact surfaces that can potentially impact protein stability and propensity for aggregation. These forces can vary as fluid flow rates and component design elements scale alongside batch size.

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This application note provides data demonstrating high productivity, extended cycling durability performance of membrane-based GORE Protein Capture Devices with Protein A across two rapid Clean-in-Place methods bracketing caustic contact time and concentration. These data were then combined with results from a manufacturing-scale demonstration to extrapolate protein capture capabilities at a 2000 L batch bioreactor size across CIP methods.

This application note demonstrates the scalability across multiple GORE Protein Capture Device sizes through dynamic binding capacity, CHO cell harvest, and purification experiments as demonstrated with a partially purified monoclonal antibody.

This application note demonstrates utilizing a rapid CIP and optimizing the loading and non-loading residence times during cycling to achieve increased productivity on a Gore Protein Capture Device. The method is easily transferred from lab scale to pilot scale sizes as demonstrated using both PROA101 (1mL) and PROA201 (58 mL) Gore Protein Capture Devices.

This technical note provides evidence based through ELISA assays that the GORE® Protein Capture Device did not have carryover after consecutive cycling of two different cell culture harvests when separated by a 15-minute sanitization cycle using 0.1 M NaOH.

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.