Evidence map›Paper›PMID 29492680›Full record

ArticlePharmaceutical research2018

Formulation Stabilization and Disaggregation of Bevacizumab, Ranibizumab and Aflibercept in Dilute Solutions.

Steven A Giannos, Edward R Kraft, Zhen-Yang Zhao, Kevin H Merkley, Jiyang Cai

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmaceutical research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.0field-weighted citation impact, top 14% 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

12 citing papers in PubMed, 27 citations in OpenAlex.

  1. Review
  2. Local controlled release of stabilized monoclonal antibodies.Journal of controlled release : official journal of the Controlled Release Society · 2025
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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

5 authors at 1 institution in 1 country.

Steven A GiannosDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, 301 University Blvd, Galveston, Texas, 77555, USA. stgianno@utmb.edu.
Edward R KraftDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, 301 University Blvd, Galveston, Texas, 77555, USA.
Zhen-Yang ZhaoDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, 301 University Blvd, Galveston, Texas, 77555, USA.
Kevin H MerkleyDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, 301 University Blvd, Galveston, Texas, 77555, USA.
Jiyang CaiDepartment of Ophthalmology and Visual Sciences, University of Texas Medical Branch, 301 University Blvd, Galveston, Texas, 77555, USA.
The University of Texas Medical Branch at Galveston · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeStudies were conducted to investigate dilute solutions of the monoclonal antibody (mAb) bevacizumab, mAb fragment ranibizumab and fusion protein aflibercept, develop common procedures for formulation of low concentration mAbs and identify a stabilizing formulation for anti-VEGF mAbs for use in in vitro permeation studies.

methodsExcipient substitutions were screened. The most stabilizing formulation was chosen. Standard dilutions of bevacizumab, ranibizumab and aflibercept were prepared in PBS, manufacturer's formulation, and the new formulation. Analysis was by SE-HPLC and ELISA. Stability, disaggregation and pre-exposure tests were studied.

resultsWhen Avastin, Lucentis and Eylea are diluted in PBS or manufacturer's formulation, there is a 40-50% loss of monomer concentration and drug activity. A formulation containing 0.3% NaCl, 7.5% trehalose, 10 mM arginine and 0.04% Tween 80 at a pH of 6.78 stabilized the mAbs and minimized the drug loss. The formulation also disaggregates mAb aggregation while preserving the activity. Degassing the formulation increases recovery.

conclusionsWe developed a novel formulation that significantly stabilizes mAbs under unfavorable conditions such as low concentration or body temperature. The formulation allows for tissue permeation experimentation. The formulation also exhibits a disaggregating effect on mAbs, which can be applied to the manufacture/packaging of mAbs and bioassay reagents.

Indexed as

Angiogenesis InhibitorsBevacizumabBiological AssayBiological ProductsDrug CompoundingDrug StabilityExcipientsProtein AggregatesRanibizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsSolutionsTemperatureafliberceptAngiogenesis InhibitorsBevacizumabBiological ProductsExcipientsProtein AggregatesRanibizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsSolutionsafliberceptbevacizumabELISAranibizumabSE-HPLC

Identifiers

PMID29492680
PMCPMC5830485
OpenAlexW2791608444

What OpenQuestion holds

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LicenceCC BY
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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.