ArticlemAbs
Development of adsorptive hybrid filters to enable two-step purification of biologics.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed.
- Tunable retention and recovery via pore-to-particle interactions in amine functionalized micro- and ultrafiltration Membranes: Towards scalable viral vector purification.Journal of membrane science · 2026Article
- Membrane Filtration of Nanoscale Biomaterials: Model System and Membrane Performance Evaluation for AAV2 Viral Vector Clarification and Recovery.Nanomaterials (Basel, Switzerland) · 2025Article
- Chromatographic capture of cells to achieve single stage clarification in recombinant protein purification.Biotechnology progress · 2022Article
- Analysis of fouling and breakthrough of process related impurities during depth filtration using confocal microscopy.Biotechnology progress · 2022Article
- The uniqueness of flow in probing the aggregation behavior of clinically relevant antibodies.Engineering reports : open access · 2020Article
- DNA RETENTION ON DEPTH FILTERS.Journal of membrane science · 2019Article
- Automation of an integrated micro-scale platform for monoclonal antibody process development by incorporation of a depth filter mimic.Biotechnology progressArticle
- Enhancing rapid Protein A performance in monoclonal antibody processing: Anion exchange chromatographic clarification.Biotechnology progressArticle
- Depth filter material process interaction in the harvest of mammalian cells.Biotechnology progressArticle
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Recent progress in mammalian cell culture process has resulted in significantly increased product titers, but also a substantial increase in process- and product-related impurities. Due to the diverse physicochemical properties of these impurities, there is constant need for new technologies that offer higher productivity and improved economics without sacrificing the process robustness required to meet final drug substance specifications. Here, we examined the use of new synthetic adsorptive hybrid filters (AHF) modified with the high binding capacity of quaternary amine (Emphaze™ AEX) and salt-tolerant biomimetic (Emphaze™ ST-AEX) ligands for clearance of process-related impurities like host cell protein (HCP), residual DNA, and virus. The potential to remove soluble aggregates was also examined. Our aim was to develop a mechanistic understanding of the interactions governing adsorptive removal of impurities during filtration by evaluating the effect of various filter types, feed streams, and process conditions on impurity removal. The ionic capacity of these filters was measured and correlated with their ability to remove impurities for multiple molecules. The ionic capacity of AHF significantly exceeded that of traditional adsorptive depth filters (ADF) by 40% for the Emphaze™ AEX and by 700% for the Emphaze™ ST-AEX, providing substantially higher reduction of soluble anionic impurities, including DNA, HCPs and model virus. Nevertheless, we determined that ADF with filter aid provided additional hydrophobic functionality that resulted in removal of higher molecular weight species than AHF. Implementing AHF demonstrated improved process-related impurity removal and viral clearance after Protein A chromatography and enabled a two-step purification process. The consequences of enhanced process performance are far reaching because it allows the downstream polishing train to be restructured and simplified, and chromatographic purity standards to be met with a reduced number of chromatographic steps.
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