Evidence map›Paper›PMID 29855993›Full record

ArticleImmunologic research2018

A new CHO (Chinese hamster ovary)-derived cell line expressing anti-TNFα monoclonal antibody with biosimilar potential.

Mateus Dalcin Luchese, Mariana Lopes Dos Santos, Angelica Garbuio, Roselaine Campos Targino, Carla Ploeger Mansueli, Lilian Rumi Tsuruta, Wagner Quintilio, Ana Maria Moro

Abstract read
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In one paragraph

Article in Immunologic research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.4field-weighted citation impact, top 40% 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

3 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
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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

8 authors at 1 institution in 1 country.

Mateus Dalcin LucheseLaboratório de Biofármacos em Células Animais, Instituto Butantan, Av. Vital Brasil 1500, São Paulo, SP, 05503-900, Brazil.
Mariana Lopes Dos SantosLaboratório de Biofármacos em Células Animais, Instituto Butantan, Av. Vital Brasil 1500, São Paulo, SP, 05503-900, Brazil.
Angelica GarbuioLaboratório de Biofármacos em Células Animais, Instituto Butantan, Av. Vital Brasil 1500, São Paulo, SP, 05503-900, Brazil.
Roselaine Campos TarginoLaboratório de Biofármacos em Células Animais, Instituto Butantan, Av. Vital Brasil 1500, São Paulo, SP, 05503-900, Brazil.
Carla Ploeger MansueliLaboratório de Biofármacos em Células Animais, Instituto Butantan, Av. Vital Brasil 1500, São Paulo, SP, 05503-900, Brazil.
Lilian Rumi TsurutaLaboratório de Biofármacos em Células Animais, Instituto Butantan, Av. Vital Brasil 1500, São Paulo, SP, 05503-900, Brazil.
Wagner QuintilioLaboratório de Biofármacos em Células Animais, Instituto Butantan, Av. Vital Brasil 1500, São Paulo, SP, 05503-900, Brazil.
Ana Maria MoroLaboratório de Biofármacos em Células Animais, Instituto Butantan, Av. Vital Brasil 1500, São Paulo, SP, 05503-900, Brazil. ana.moro@butantan.gov.br.
Instituto Butantan · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Tumor necrosis factor alpha (TNFα) is a pro-inflammatory cytokine that mediates the homeostasis of immune responses; its exacerbated production is associated with the pathogenesis of autoimmune and chronic inflammatory diseases. Anti-TNFα drugs have revolutionized the treatment of inflammatory conditions such as rheumatoid arthritis and Crohn's disease. Currently, a worldwide race is on stage for the production of biosimilars moved by patent expiration of monoclonal antibodies (mAbs), such as anti-TNFα adalimumab. Our goal was to develop the first stage of an adalimumab biosimilar candidate with potential for national production, through the generation of a productive and stable cell line and assess its functionality. The robotic system ClonePix was used for screening and isolation of colonies from transfected CHO-S stable pools plated in semisolid medium. Selected clones were expanded based on growth and productivity. Purified mAbs from different clones were tested for binding and functional activity. The binding affinity of the denominated adabut clones to TNFα and FcRγ did not differ statistically when compared to reference adalimumab. One functional activity assay demonstrated the antibody neutralization capacity of the cytotoxicity induced by TNFα in L929 murine fibroblasts. A second assay confirmed adabut as an antagonist of the TNFα activity by the inhibition of the cell adhesion molecule expression in HUVEC cultures. The binding and functional activity analyses performed with selected adabut clones in comparison to reference adalimumab represent an important status of "non-inferiority," part of the process required for a biosimilar development. We generated and selected high-quality adabut clones which mAbs may be further developed as the first in-house made Brazilian biosimilar, demonstrating a success case for our incipient biotechnology industry, or also modified as biobetters, thus representing an innovative strategy for the patients' welfare.

Indexed as

Biosimilar PharmaceuticalsAdalimumabAnimalsAntibodies, MonoclonalAntibodies, NeutralizingCell LineCells, CulturedCell SurvivalCHO CellsCricetinaeCricetulusHumansMiceRecombinant Fusion ProteinsTumor Necrosis Factor-alphaAdalimumabAntibodies, MonoclonalAntibodies, NeutralizingBiosimilar PharmaceuticalsRecombinant Fusion ProteinsTumor Necrosis Factor-alphaAutoimmunityBiosimilarCHO cellsClonePix-FLClone selectionMonoclonal antibodySPRTNFα

Identifiers

PMID29855993
OpenAlexW2806066622

What Socratic 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 Socratic graph.