Evidence map›Paper›PMID 39339258›Full record

ArticlePharmaceutics2024

Comprehensive Analysis of Cetuximab Critical Quality Attributes: Impact of Handling on Antigen-Antibody Binding.

Alicia Torres-García, Anabel Torrente-López, Jesús Hermosilla, Amparo Hernández, Antonio Salmerón-García, José Cabeza, Natalia Navas

Abstract read
In one paragraph

Article in Pharmaceutics, 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

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. 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

7 authors.

Alicia Torres-GarcíaFundación para la Investigación Biosanitaria de Andalucía Oriental (FIBAO), Hospital Doctor Olóriz, Avda de Madrid, 15, Pabellón de Consultas Externas 2, 2ª Planta, 18012 Granada, Spain.ORCID 0009-0005-6132-6228
Anabel Torrente-LópezInstituto de Investigación Biosanitaria ibs.GRANADA, Avda de Madrid, 15, 18012 Granada, Spain.ORCID 0000-0002-2507-6760
Jesús HermosillaInstituto de Investigación Biosanitaria ibs.GRANADA, Avda de Madrid, 15, 18012 Granada, Spain.ORCID 0000-0002-2390-2360
Amparo HernándezAnalytical Chemistry Department, Science Faculty, Universidad de Granada, Avenida Fuentenueva s/n, 18071 Granada, Spain.
Antonio Salmerón-GarcíaInstituto de Investigación Biosanitaria ibs.GRANADA, Avda de Madrid, 15, 18012 Granada, Spain.
José CabezaInstituto de Investigación Biosanitaria ibs.GRANADA, Avda de Madrid, 15, 18012 Granada, Spain.ORCID 0000-0002-2161-930X
Natalia NavasInstituto de Investigación Biosanitaria ibs.GRANADA, Avda de Madrid, 15, 18012 Granada, Spain.ORCID 0000-0002-2536-1430

Funding

Instituto de Salud Carlos III FIS-PI17-00547
6 · The paper itself

Abstract

BACKGROUND/

objectivesCetuximab, formulated in Erbitux

methodsIn this study, we conducted a deep physicochemical and functional characterization of the critical quality attributes of cetuximab in control samples and under controlled degraded conditions, including freeze-thaw cycles, heat, agitation, and light exposure. To achieve this purpose, we used a set of proper analytical techniques, including CD, IT-FS, DLS, SE/UHPLC-UV, UHPLC-MS/MS, and ELISA, to check functionality based on antigen-antibody binding.

resultsThe results revealed that light exposure was the stress stimuli with the greatest impact on the drug product, leading to the formation of non-natural oligomers, fragmentation, and oxidation of methionine residues. Additionally, cetuximab (Erbitux

conclusionsThus, we suggest that Erbitux

Indexed as

cetuximab characterizationcomprehensive analysisELISAErbitux® analysisforced degradationpeptide mapping-RP/UHPLC-MS/MSstability study

Identifiers

PMID39339258
PMCPMC11435379

What OpenQuestion holds

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Registered trials

None linked

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.