On the achievable consistency of glycan distribution in biomanufacturing of therapeutic mAbs.

Hongbin Zhu, Joshua Shipman, Weiming Ouyang, Kang Chen

Abstract read

In one paragraph

Article in NPJ advanced manufacturing, 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

4 authors.

Hongbin ZhuDivision of Pharmaceutical Quality and Research II, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, St. Louis, MO, USA.

Joshua ShipmanDivision of Pharmaceutical Quality and Research II, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, St. Louis, MO, USA.

Weiming OuyangDivision of Pharmaceutical Quality and Research III, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Kang ChenDivision of Pharmaceutical Quality and Research II, Office of Pharmaceutical Quality Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Funding

Intramural FDA HHS FD999999

6 · The paper itself

Abstract

Recombinant monoclonal antibody (mAb) therapeutics exhibit lot-to-lot glycosylation variation influenced by manufacturing processes, which remains underexplored publicly. This study analyzed five years of trastuzumab and adalimumab lots, revealing up to 4% range of variation in glycan relative abundance and significant change or drift of ~1% by ANOVA, levels unlikely to affect mAb efficacy or safety. The results suggest that modern manufacturing can maintain consistent glycan profiles within realistically achievable ranges.

Identifiers

PMID41696651

DOI10.1038/s44334-025-00058-5

PMCPMC12895347

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.