ArticleJournal of separation science2026
Multiple Heart-Cut Ion-Exchange Chromatography-Reversed-Phase Liquid Chromatography Platform for Online Desalting and Fractionation of Monoclonal Antibody Charge Variants.
Article in Journal of separation science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
Minor deviations in biopharmaceutical manufacturing processes, such as those used for monoclonal antibodies (mAbs), can introduce structural modifications that alter protein efficacy and safety. Monitoring these changes is critical to ensure product consistency and efficacy. Ion-exchange chromatography (IEC) is widely employed to assess product quality by separating charge variants. However, the use of non-volatile salts in IEC makes direct identification and characterization of these variants difficult. In this study, we developed a multi-heart-cut IEC-reversed-phase liquid chromatography (RPLC) platform that enables the separation, online concentration, desalting, and fractionation of mAb charge variants. The system integrates a 10-port valve and a six-column selector valve, allowing automated collection of up to five charge variants within a single analytical workflow. Moreover, the platform can be directly coupled to mass spectrometry for the characterization of charge heterogeneity and glycosylation. Systematic optimization of the capture and buffer-exchange conditions, including evaluation of stationary phase types and mobile phase compositions, was performed to maximize overall recovery. This platform can also be used for other chromatographic modes, such as hydrophobic interaction chromatography or size-exclusion chromatography. This integrated multiple heart-cut IEC-RPLC platform provides a high-resolution and efficient platform for detailed characterization of mAb charge variants, facilitating the characterization of critical product quality attributes.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.