Evidence map›Paper›PMID 41149977›Full record

ArticleMembranes2025

Removal of Aggregates During Bispecific Antibody Purification Using Hydrophobic Interaction Chromatography.

Puya Zhao, Yue Qi, Kai Gao

Abstract read
In one paragraph

Article in Membranes, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Puya ZhaoShanghai AsymChem Biotechnology Co., Ltd., Building 8, No.12, Lane 855, Jinzheng Road, Jinshan Industrial Park, Shanghai 201507, China.ORCID 0009-0007-0555-8758
Yue QiShanghai AsymChem Biotechnology Co., Ltd., Building 8, No.12, Lane 855, Jinzheng Road, Jinshan Industrial Park, Shanghai 201507, China.
Kai GaoShanghai AsymChem Biotechnology Co., Ltd., Building 8, No.12, Lane 855, Jinzheng Road, Jinshan Industrial Park, Shanghai 201507, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In the production of recombinant antibody/Fc-fusion proteins using mammalian cells, many aggregates often form alongside the target proteins, particularly with bispecific antibodies. To ensure the safety of biological products, it is essential to control the amount of aggregates within a specific range. A traditional downstream process typically involves using Protein A (ProA) resin to capture the target antibody, followed by two polishing steps to ensure purity; for instance, using an anion exchange chromatography (AEX) in flow-through mode and a cation exchange chromatography (CEX) in binding-elution mode. In this study, we choose a Dual Action Fab (DAF), which can bind two antigens and is prone to aggregation when expression in CHO (Chinese Hamster Ovary) cells. We introduce hydrophobic interaction membrane chromatography (HIMC) operating in flow-through mode, which enhances production efficiency while reducing costs and the risks associated with column packing. We evaluated the impact of the operating buffer system, as well as the pH and conductivity of the loading samples, on aggregate removal using HIMC. Additionally, we investigated the mechanism of aggregate binding and found that loading conditions had a limited impact on this process. Overall, our findings indicate that employing HIMC can achieve a 20% reduction in aggregate levels. These results demonstrate that HIMC in flow-through mode is an effective and robust approach for reducing aggregates during antibody purification.

Indexed as

downstream processflow-through modemembrane chromatographyquality by design

Identifiers

PMID41149977
PMCPMC12566258

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.