Protein A chromatography has been an industry standard in the downstream processing of mAb for more than a decade. A typical Protein A based mAb purification platform employs one or two more chromatography columns to remove trace amounts of process related impurities like HCP, DNA, leached Protein A and product-related impurities like aggregates. Cation-exchange chromatography is very efficient at the separation of HCP, leached Protein A and product-related impurities such as aggregates and fragments in bind and elute mode. This study compares bind and elute mAb purification performance with that in flowthrough mode for the Natrix HD-Sb hydrogel membrane. Natrix HD-Sb is a salt-tolerant strong cation-exchange membrane augmented with hydrophobic butyl groups. This study will show the mAb purification performance of Natrix HD-Sb membrane using two challenging feed, one having high amounts of aggregates and another having high HCP. The effectiveness of Natrix HD-Sb in removing aggregates and HCP from a challenging feed at high load with significant improvement in productivity and simplicity will be highlighted.

Natrix HD-Sb membrane adsorber: A new high-performance purification tool for mAb purification in flowthrough mode

251st National Meeting (2016)

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