| Sumario: | Continuous bioproduction processes have recently seen a flood of development activity. A key technology that can help achieve a continuous production flow is single-pass tangential flow filtration (SPTFF); a continuous tangential flow filtration (TFF) operation with a simple, straight-through flow path without a recirculation loop. SPTFF is performed at lower feed flow rates than those of batch TFF operations. SPTFF is used to directly link different unit operations (i.e., to alter in-line buffer composition and product concentration or to increase the final concentration at high yield). However, there are limitations in the available options and flow rates used for cleaning the filters. Yet, the high value of TFF devices makes the assessment of reuse by cleaning economically interesting. This article highlights a case study in which a static cleaning methodology was applied for SPTFF. To maintain the simplicity of the straight-through flow path, a cleaning procedure was assessed using a combination of flushing and static hold steps without recirculation. The cleaning procedure efficacy and its effect on process performance over multiple cycles of a monoclonal antibody process were evaluated.
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