Evidence map›Paper›PMID 39553673›Full record

ArticleHeliyon2024

A novel technique for trehalose and sucrose determination in therapeutic monoclonal antibodies using a high-performance liquid chromatography-evaporative light scattering detector.

Xiaojuan Yu, Zhanlei Xing, Lan Wang, Chuanfei Yu

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Heliyon, 2024. 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

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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. Article
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.

Xiaojuan YuKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, 102629, China.
Zhanlei XingAgilent Technologies, Inc, Beijing, 100102, China.
Lan WangKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, 102629, China.
Chuanfei YuKey Laboratory of the Ministry of Health for Research on Quality and Standardization of Biotech Products, National Institutes for Food and Drug Control, Beijing, 102629, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sucrose and trehalose are commonly used excipients in therapeutic monoclonal antibodies that play a pivotal role in ensuring the safety and stability of drugs. Though it is necessary to control the concentrations of these substances during the quality control of their release, there is currently no comprehensive method for simultaneously determining sucrose and trehalose concentrations. Herein, we established a high-performance liquid chromatography-evaporative light scattering detector (HPLC-ELSD) method and validated it in accordance with the International Council for Harmonization Q2 guidelines. This method utilized the Poroshell 120 HILIC-Z chromatographic column and effectively separated sucrose and trehalose with a detection limit of 0.001 mg/mL. The accuracy recovery rate was within a range of 90%-110 %, and the precision relative standard deviations were all less than 5.0 % (n = 6). The method thus demonstrated good repeatability and linearity, making it suitable for determining the sucrose and trehalose concentrations in therapeutic monoclonal antibodies.

Indexed as

Evaporative light scattering detectorHigh-performance liquid chromatographySucroseTherapeutic monoclonal antibodiesTrehalose

Identifiers

PMID39553673
PMCPMC11567030

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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.