A UF – DF Screening System for Bioprocess Development Efficient and Cost-Effective Process Fit and Scale-Up to Manufacturing

U ltrafiltration and diafiltration (UF–DF) of therapeutic proteins are performed in either tangential or crossf low mode using membrane filters. UF–DF plays a critical role in both downstream and upstream processes for the biopharmaceutical industry (1). In upstream production processes, classical tangential-f low filtration (TFF) or alternating tangential-f low (ATF) systems are used in high–celldensity perfusion for protein expression by cell culture (2). TFF is used in downstream processing for UF–DF and concentration of therapeutic proteins. TFF unit operations are common in protein purification because of their scalability and amenability to continuous processing (3–5). Typical TFF process development involves optimization of transmembrane pressure (TMP), permeate f lux, feed f lowrate, buffer compositions, and the interdependence of all those parameters. Optimization requires a broadly defined design space and many experiments needing significant time and resource investments. With speed to first-in-human initiatives leading to shrinking timelines in early process development, the demand for enhanced throughput has increased significantly in recent years. Expedited timelines and minimal material availability in early phases complicate process development of TFF. For increased throughput on