Microfluidic filtration device for high throughput process development

Sustainable biopharmaceutical manufacturing requires cost-effective, scalable, and efficient processes. To achieve this goal, access to scalable screening platforms providing rapid and high-quality data with low material requirements is required. While cell culture/fermentation and purification technologies meeting these criteria have been developed and deployed, microscale filtration solutions, which enable screening a wide range of filtration products and conditions, are largely absent. Microfluidic filtration devices are uniquely positioned to fill this technology gap since they can provide the necessary throughput for screening applications with low feed volumes and in-line monitoring. However, a lack of standardized approaches limits their industrial adoption. We present a microfluidic tangential flow filtration (μTFF) device that can accommodate any flat sheet-membrane. Membrane exchange is straightforward, enabling application in single-use or re-use formats. We successfully tested a wide flux range (30–1055 litres per square meter per hour, LMH), observed recovery yields exceeding 80 % in single-pass mode (1 bar transmembrane pressure, TMP), and demonstrated cleaning in place (CIP) procedures for extended membrane use with multiple filtration cycles (recoveries > 80 %). Furthermore, we integrated sensors to facilitate automation and generation of scale-relevant data, and provided criteria to facilitate pump selection. Our μTFF device offers, therefore, a standardised design paving the way for off-the-shelf microfluidic solutions for filtration optimisation, thus enhancing efficiency and effectiveness of bioprocess development.