Evaluation of HCP and DNA Clearance with NatriFlo™ HD-Q Membrane Adsorbers at Lab to Process Scales

NatriFlo™ HD-Q chromatography from Natrix Separations introduces reliable and reproducible Q polish performance that combines resin binding capacity with adsorber speed to achieve a new level of process flexibility. Gallus Biopharmaceuticals (a St. Louis based CMO) evaluated NatriFlo™ HD-Q membrane columns as an anion exchange polishing step with the objective of assessing NatriFlo’s ability to (1) reduce process-derived impurities to achieve target product profile; (2) maintain process robustness to process changes; and (3) achieve reliable scalability from lab to production. This case study illustrates Gallus’ findings, including constant HCP clearance to ~20 ppm across a range of loads (up to 10 kg/L), consistent HCP clearance across device scales, and the ability of the NatriFlo HD-Q membrane to operate robustly with a phosphate buffer system. Gallus’ testing also demonstrated excellent DNA clearance (not covered in this case study).