Increase Productivity With Rapid CIP Using Protein Capture Devices With Protein A

By Lauren Parker, Jeffrey Cassel, Mike McManaway and William C. Barrett, Ph.D., W. L. Gore & Associates, Inc.

GORE® Protein Capture Devices with Protein A (GPCD) is capable of completing 200 purification cycles with the rapid CIP method while maintaining dP < 0.25 MPa, elution width < 3.2 CVs, and yield >90%. This was tested with a 1.0 mL device (PROA101) cycling method from PB12180 employed with adjustments to use less equilibration buffer (TBS) for re-equilibration and to include a post-load flush with TBS at the same loading flow rate to account for system hold-up volume and allow the remaining harvest in the line to bind at the appropriate loading residence time.

This GORE® Protein Capture Devices with Protein A demonstration showcases both the cycling protocol and a rapid CIP out to 100 cycles to achieve all critical quality attributes, including endotoxin and bioburden, while increasing productivity and reducing buffer consumption.