Integrity Testing of Ultrafiltration Systems for Biopharmaceutical Applications

摘要

Ultrafiltration (UF) is a membrane-based separation technology commonly used in the biopharmaceutical industry for concentration or diafiltration of protein solutions to remove low-molecular-weight (LMW) impurities or exchange buffers. The nominal MWlimit of UF membranes ranges from 1,000 Da (1 kDa) to 1,000,000 Da (1,000 kDa). A target product is retained by the membrane while lower-MW solutes or impurities pass through (l). For a target product with a smaller MW than the impurities, separation isaccomplished by allowing the product to pass through the membrane into the permeate side instead.