Evidence map›Paper›PMID 41926056›Full record

ArticleBioresources and bioprocessing2026

Enhanced cleaning strategies for UF/DF membranes in biopharmaceutical downstream processing.

Xinye Han, Zhenhao Bian, Xuyue Han, Huaguang Wang, Han Liu, Yajuan Zhou, Yiqing Cui, Xumei Liu

Abstract read
In one paragraph

Article in Bioresources and bioprocessing, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Xinye HanDownstream Process Development (DSPD), WuXi Biologics, No.200 Meiliang Road, Binhu District, Wuxi, 214092, Jiangsu, China.
Zhenhao BianDownstream Process Development (DSPD), WuXi Biologics, No.200 Meiliang Road, Binhu District, Wuxi, 214092, Jiangsu, China.
Xuyue HanDownstream Process Development (DSPD), WuXi Biologics, No.200 Meiliang Road, Binhu District, Wuxi, 214092, Jiangsu, China.
Huaguang WangDownstream Process Development (DSPD), WuXi Biologics, No.200 Meiliang Road, Binhu District, Wuxi, 214092, Jiangsu, China.
Han LiuDownstream Process Development (DSPD), WuXi Biologics, No.200 Meiliang Road, Binhu District, Wuxi, 214092, Jiangsu, China.
Yajuan ZhouDownstream Process Development (DSPD), WuXi Biologics, No.200 Meiliang Road, Binhu District, Wuxi, 214092, Jiangsu, China.
Yiqing CuiDownstream Process Development (DSPD), WuXi Biologics, No.200 Meiliang Road, Binhu District, Wuxi, 214092, Jiangsu, China.
Xumei LiuDownstream Process Development (DSPD), WuXi Biologics, No.200 Meiliang Road, Binhu District, Wuxi, 214092, Jiangsu, China. liu_xumei@wuxibiologics.com.ORCID http://orcid.org/0009-0002-8083-4840

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Membrane fouling during ultrafiltration/diafiltration (UF/DF) remains a major challenge for extending membrane lifetime in biologics manufacturing. Developing cleaning strategies that combine high efficiency with scalability is essential for robust downstream processing. In this study, different UF/DF membrane cleaning methods were assessed under bench-scale conditions with consideration for large-scale implementation. Permeate-closed cleaning (PCC), which temporarily closes the permeate port to enhance shear, effectively mitigated normalized water permeability (NWP) decline. Furthermore, forward and reverse PCC at elevated feed flux achieved comparable fouling control with fewer steps by leveraging hydrodynamic shear and localized backwashing. To simplify large-scale adoption, high-flux PCC was developed and demonstrated the ability to restore NWP and maintain stability over extended cycles. Quantitatively, high‑flux PCC reduced early NWP decay by ~ 18% over the first three cycles and recovered > 15% NWP in previously fouled membranes, stabilizing permeability over extended reuse. Backwashing under controlled negative transmembrane pressure (TMP) further improved pore-level cleaning and extended membrane usability. Additionally, combining sodium hypochlorite (NaClO) with sodium hydroxide (NaOH) provided strong oxidative and alkaline action; within the evaluated range (25-150 ppm NaClO), 50 ppm was identified as a practical lower limit for effective recovery, while 150 ppm restored NWP from ~ 70 to ~ 100% with residual NaClO < 0.02 ppm after final rinsing. Collectively, these findings present a portfolio of cleaning strategies-hydrodynamic, chemical, and combined approaches-that enhance cleaning efficiency, reduce chemical exposure, and support sustainable UF/DF operations in biologics manufacturing.

Indexed as

BackwashingBiologics downstream processingCleaning strategiesMembrane foulingPermeate-closed cleaningUltrafiltration/diafiltration (UF/DF)

Identifiers

PMID41926056
PMCPMC13046915

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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.