Evidence map›Paper›PMID 36175743›Full record

ArticleAAPS PharmSciTech2022

Photodegradation of Rituximab and Critical Evaluation of Its Sensibility to Electromagnetic Radiation.

Víctor Pérez Medina Martínez, Miriam Cedillo Robles, Laura Carmina Juárez-Bayardo, Carlos E Espinosa-de la Garza, Angélica Meneses, Néstor O Pérez

Abstract read
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In one paragraph

Article in AAPS PharmSciTech, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 27% of its field
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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. 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

6 authors at 1 institution in 1 country.

Víctor Pérez Medina MartínezUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., C. P. 52400, Tenancingo, Estado de México, Mexico.
Miriam Cedillo RoblesDirección de Calidad, Probiomed S.A. de C.V., C.P. 11520, Cd. de México, Mexico.
Laura Carmina Juárez-BayardoUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., C. P. 52400, Tenancingo, Estado de México, Mexico.
Carlos E Espinosa-de la GarzaUnidad de Investigación y Desarrollo, Probiomed S.A. de C.V., C. P. 52400, Tenancingo, Estado de México, Mexico.
Angélica MenesesUniversidad Autónoma del Estado de Morelos, C.P. 62210, Cd. de Cuernavaca, Mexico.
Néstor O PérezDirección de Operaciones, Probiomed S.A. de C.V., C.P. 11520, Cd. de México, Mexico. nestor.perez@probiomed.com.mx.
Universidad Autónoma del Estado de Morelos · MX

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Rituximab is a monoclonal antibody used in the treatment of lymphoma non-Hodgkin. This mAb is photosensitive as it is administrated to the patient by infusion/perfusion; therefore, photostability is a decisive factor in the efficacy of this biologic. To better understand the photodegradation mechanisms of Rituximab, this biologic was exposed to different irradiance conditions. We show in this study that this mAb photodegrade proportionally to irradiance intensities. The main modifications of Rituximab by irradiance correlate to the increase in aggregates, decrease in its Tm, acidic charge variants, oxidation of the Trp (36) in the heavy chain, and decrease in complement-dependent cytotoxicity (CDC) potency. To understand the relationship between real-life photo-exposition conditions and ICH standardized light tests, a full characterization was set up. Worst photo-stress cases were evaluated, 1 and 2 h under direct sunlight through a window, mimicking the ID65 electromagnetic radiation profile. Our results show that only exposition to direct sun irradiance during 2 h, (≈ 150 kluxes•h), increases critically soluble and insoluble aggregates, diminishing Tm, increasing acidic charge variants, and the photooxidation of the Trp (36) in the heavy chain measured by peptide mapping-RP-UPLC-MS. A decrease in CDC below 80% resulted under this condition, which correlates with physicochemical analyses. While inside light-room exposition (similar to ICH test) and ICH conditions do not have any contribution to the degradation of Rituximab measured by these physicochemical and biological analytical methods. These results indicate that exposition of Rituximab to below ≈ 75 kluxes•h of sun light cannot photodegrade critically this biologic inside of its primary container.

Indexed as

Biological ProductsTandem Mass SpectrometryAntibodies, MonoclonalChromatography, LiquidElectromagnetic RadiationHumansPhotolysisRituximabAntibodies, MonoclonalBiological ProductsRituximabacidic charge variantsphotodegradationphotostabilityrituximabsolar irradiance

Identifiers

PMID36175743
OpenAlexW4297989852

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.