Configurability and Compliance for Automated TFF up to 500L

Driven by the rise in cell and gene therapies, TFF unit operations at scales from 10 mL to 500 L now require the single-use, automation and data integrity capabilities previously reserved for larger scale systems. The newly developed KrosFlo® KMPi TFF System from Repligen provides walk-away automation for concentration, diafiltration and fed-batch processes with TMP control, closed and single-use flow paths and 21 CFR Part 11 software compliance for processes up to 500L. Key components to this new system include: a patented automatic back-pressure control valve, a proprietary control board that enables plug-and-play hardware connectivity and modern software built upon a secure SQL database. Key technical features and applications supported by flexible configurations of the KrosFlo® KMPi TFF System will be discussed.