Evidence map›Paper›PMID 42450343›Full record

ReviewInternational journal of molecular sciences2026

Analytical Ultracentrifugation for Biopharmaceutical Characterization and Quality Control.

Xiaojuan Yu, Wendan Chu, Qing Chang, Kaiyue Zhao, Zhaoxing Wang, Chengshi Zeng, Lan Wang, Chuanfei Yu, Wenqi Li

Abstract readReview
PubMed Full text at PMC Publisher
In one paragraph

Review in International journal of molecular sciences, 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

9 authors.

Xiaojuan YuState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Wendan ChuBeijing Frontier Research Center for Biological Structure, Tsinghua University, Beijing 100084, China.ORCID 0000-0003-0598-390X
Qing ChangBeijing Frontier Research Center for Biological Structure, Tsinghua University, Beijing 100084, China.ORCID 0000-0002-9259-7734
Kaiyue ZhaoState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Zhaoxing WangBeijing Frontier Research Center for Biological Structure, Tsinghua University, Beijing 100084, China.
Chengshi ZengBeijing Frontier Research Center for Biological Structure, Tsinghua University, Beijing 100084, China.
Lan WangState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Chuanfei YuState Key Laboratory of Drug Regulatory Science, NHC Key Laboratory of Research on Quality and Standardization of Biotech Products, NMPA Key Laboratory for Quality Research and Evaluation of Biological Products, National Institutes for Food and Drug Control, Beijing 102629, China.
Wenqi LiBeijing Frontier Research Center for Biological Structure, Tsinghua University, Beijing 100084, China.

Funding

Beijing Frontier Research Center for Biological Structure and the Technology Center for Protein Sciences 997019045Control of Emerging and Major Infectious Diseases-National Science and Technology Major Project 2025ZD01904200Research Project for the Formulation and Revision of National Drug Standards 2024S04State Key Laboratory of Drug Regulatory Science Project 2025SKLDRS0318
6 · The paper itself

Abstract

Modern biotechnology has rapidly developed, and biotechnological drugs have become the center of global drug research and development as an important aspect of clinical treatment. These drugs have unique advantages, such as strong species specificity and prominent targeting, and they are widely used in the treatment of various intractable diseases. However, their complex molecular structure, poor stability, and significant heterogeneity make quality control much more difficult than that of traditional small-molecule drugs that require high-precision analytical methods. Analytical ultracentrifugation (AUC) technology was pioneered by Theodor Svedberg during the early 20th century, and it has become an indispensable biophysical tool through technological innovation. This technology has unique advantages for the quality control of biotechnological drugs, including non-destructive detection, high resolution, and wide applicability. Therefore, AUC has been extensively adopted for the characterization of various biological products. This review systematically summarizes AUC technology applications in major categories of biotechnological drugs, with the aim to provide technical guidance and promote the standardized application of AUC.

Indexed as

Biological ProductsUltracentrifugationAnimalsHumansQuality ControlBiological Productsanalytical ultracentrifugationbiopharmaceuticalsquality control

Identifiers

PMID42450343
PMCPMC13362246

What OpenQuestion holds

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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.