Navigating Complex URS Demands: Demonstrating Process Fit With A Single-Use TFF System

Scaling an ultrafiltration process across manufacturing sites requires more than replicating existing parameters. Equipment configurations, facility capabilities, and user requirement specifications (URS) can introduce constraints that affect process fit. During a recent technology transfer for a global biomanufacturer, a facility-fit challenge required a new approach to membrane loading. Adam shares how MSAT engineers evaluated the constraint and developed a strategy that increased membrane loading by 50% without compromising process performance. The resulting work demonstrated that the ultrafiltration process could operate successfully within the new site’s requirements.

Examine the engineering considerations behind the solution and how a structured, data-driven approach supported both process scale-up and successful technology transfer.