ArticlePharmaceutics2024
Assessing Protein Content and Dimer Formation in the Bevacizumab Reference Product and Biosimilar Versions Marketed in Spain.
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.
What it found
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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.
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.
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe manufacture of biologics is a complex, controlled, and reproducible process that results in a product that meets specifications. This should be based on data from batches used to demonstrate manufacturing consistency. Ten batches of originator product (Avastin
methodsThe β-expectation tolerance intervals and the process capability analysis were proposed to establish the specification limits for determining the acceptance criteria of the final product from the manufacturing process. Protein concentration and dimer content were utilized as CQAs. The analytical similarity between three biosimilars authorized in Spain since 2021 (Vegzelma
resultsThe results indicate that the two main sources of variation are under control; even the level of variability observed is close to the capability of the analytical method. The manufacturing process, therefore, continues under statistical control. Similarity is demonstrated for the bevacizumab concentration regardless of the approach used, whereas similarity is demonstrated for the dimer content for only one of the biosimilar products.
conclusionsThe proposed methodologies allow for the analysis of the consistency of the manufacturing process and the variability from batch to batch.
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Registered trials
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