Pall’s Cadence™ single-pass tangential flow filtration (SPTFF) technology provides a simple solution for continuous concentration and optimization of Downstream Processing (DSP) steps. It eliminates the conventional TFF recirculation loop and allows product to be concentrated in a single pump pass. The single-pass operation eliminates any mixing or foaming issues and exposes the product to low shear; thus, it is optimal for the processing of fragile and shear-sensitive molecules as well. The single-pass feed flow rates are lower compared to conventional TFF, which minimizes the hold-up volume and maximizes product recovery. It also allows higher final concentrations to be achieved because the processing limitations due to minimum working volumes are optimized.

The Cadenceâ„¢ Inline Concentrator (ILC) utilizes Pall’s patented single-pass TFF technology. It is a new holder-less SPTFF device with a retentate flow restrictor to achieve typical concentration factors of 2 to 4X. It is thus ideal for continuous operation and process coupling. It requires minimal hardware of a feed pressure source and feed pressure measurement, minimizing any system and/or hardware requirements. When using it for single-use operation, it also eliminates any cleaning requirements or cross-contamination issues and offers many process economic advantages over re-use conventional TFF. These include up to 30% overall cost of goods savings per batch for a continuous operation, which is mainly attributed to the large savings in capital costs.

This application note describes a case study that tests the ILC module with a highly viscous feed stream prior to a final ultrafiltration and/or diafiltration step. The main objective was to test the feasibility of the ILC technology to achieve ~4X inline volume reduction prior to end user’s final UF/DF unit operation and identify processing conditions that will maximize throughput.