Configurability, single-use and compliance for with new automated flat sheet TFF up to 500L
Abstract Driven by the rise in cell and gene therapies, TFF unit operations at scales from 140 mL to 500 L now require the single-use, automation and data integrity capabilities previously reserved for larger scale systems. The newly developed KrosFlo® FS TFF Systems from Repligen provide walk-away automation for multi-step 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 500 L. Key components to this new system include: a patented automatic back-pressure control valve, a proprietary advanced microprocessor controller 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® FS TFF Systems will be discussed.
