Durability Of Membrane-Based GORE® Protein Capture Device With Protein A After Multiple Sanitization And Re-Use Cycles

By Rachael Harsch, Jonny Jackson, Feng Gu, Ph.D., Gina Dell, and Jeffrey Cassel

Repeated caustic sanitization can reduce Protein A ligand performance, making long-term consistency a key consideration in capture operations. Testing across 100 harvest purification cycles evaluated how a membrane-based GORE® Protein Capture Device responded to sodium hydroxide sanitization every 10 cycles. Results showed stable pressure, consistent elution volumes, and yields above 90% through cycle 90. Host cell protein clearance and Protein A leaching also remained consistent, while all tested bioburden and endotoxin measurements met established acceptance criteria. The device achieved an average productivity of 223 g/L/hr across the study.

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