A New Single-Use, High-Capacity Polishing Tool For mAb Purification

Strong anion exchange (Q) chromatography has become an industry standard in mAb production. It is a proven technology to remove DNA, viruses, endotoxins and acidic host cell proteins from process feed streams in flowthrough mode. Recent trends show an increasing interest in downstream single-use technologies and flexible biomanufacturing due to advancement in cell culture technology and emergence of biosimilars. Tradi-tional chromatography columns are slow, often oversized and not suitable for flexible biomanufacturing. Conventional membrane adsorbers cannot provide sufficient process robustness due to low binding capacity of membranes. These factors impose challenges on the design of purification schemes for manufacturing of biotherapeutics. However, the NatriFlo HD-Q membrane adsorbers overcome these limitations by combining high binding capacity and high flow rates to deliver best-in-class performance in single-use plug & flow format.

OBJECTIVES: This study compares dynamic BSA binding capacity of NatriFlo HD-Q with competing technologies to demonstrate performance in challenging process conditions (salt & phosphate background). It also demonstrates the effectiveness of NatriFlo HD-Q in removing process impurities (HCP, DNA & viruses) from industrial feed streams.