Evidence map›Paper›PMID 33404777›Full record

ArticleThe AAPS journal2021

Isotyping and Semi-Quantitation of Monkey Anti-Drug Antibodies by Immunocapture Liquid Chromatography-Mass Spectrometry.

Xiaoxiao Huang, Xiaobin Xu, Michael A Partridge, Jihua Chen, Ellen Koehler-Stec, Giane Sumner, Haibo Qiu, Albert Torri, Ning Li

Open access · hybridAbstract read
In one paragraph

Article in The AAPS journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.7field-weighted citation impact, top 17% 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

7 citing papers in PubMed, 15 citations in OpenAlex.

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  7. Low pKBiophysical journal · 2022
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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

9 authors at 1 institution in 1 country.

Xiaoxiao HuangAnalytical Chemistry, Regeneron Pharmaceuticals Inc., Tarrytown, New York, 10591, USA.
Xiaobin XuAnalytical Chemistry, Regeneron Pharmaceuticals Inc., Tarrytown, New York, 10591, USA. xiaobin.xu@regeneron.com.ORCID 0000-0002-4569-3133
Michael A PartridgeBioanalytical Sciences, Regeneron Pharmaceuticals Inc., Tarrytown, New York, 10591, USA.
Jihua ChenBioanalytical Sciences, Regeneron Pharmaceuticals Inc., Tarrytown, New York, 10591, USA.
Ellen Koehler-StecBioanalytical Sciences, Regeneron Pharmaceuticals Inc., Tarrytown, New York, 10591, USA.
Giane SumnerBioanalytical Sciences, Regeneron Pharmaceuticals Inc., Tarrytown, New York, 10591, USA.
Haibo QiuAnalytical Chemistry, Regeneron Pharmaceuticals Inc., Tarrytown, New York, 10591, USA. haibo.qiu@regeneron.com.
Albert TorriBioanalytical Sciences, Regeneron Pharmaceuticals Inc., Tarrytown, New York, 10591, USA.
Ning LiAnalytical Chemistry, Regeneron Pharmaceuticals Inc., Tarrytown, New York, 10591, USA.
Regeneron (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

There is an urgent demand to develop new technologies to characterize immunogenicity to biotherapeutics. Here, we developed an immunocapture LC-MS assay to isotype and semi-quantify monkey anti-drug antibodies (ADAs) to fully human monoclonal antibody (mAb) drugs. ADAs were isolated from serum samples using an immunocapture step with the Fab of the full-length mAb cross-linked to magnetic beads to minimize matrix interference. A positive monoclonal antibody control against the human immunoglobulin kappa light chain was used as a calibration standard for ADA quantitation. The final LC-MS method contains 17 multiple reaction monitoring (MRM) transitions and an optimized 15-min LC method. The results suggested that IgG1 was the most abundant isotype in ADA-positive samples. IgG2 and IgG4 were identified at lower levels, whereas IgG3 and IgA levels were only observed at very minor levels. In addition, levels of total ADA measured by the LC-MS assay were comparable to results obtained using a traditional ligand binding assay (LBA). The LC-MS ADA assay enabled rapid immunogenicity assessment with additional isotype information that LBAs cannot provide.

Indexed as

AnimalsAntibodies, MonoclonalAntibodies, NeutralizingBiological ProductsCalibrationChromatography, High Pressure LiquidDrug Evaluation, PreclinicalEnzyme-Linked Immunosorbent AssayHalf-LifeImmunoglobulin AImmunoglobulin GInjections, IntravenousMacaca fascicularisTandem Mass SpectrometryAntibodies, MonoclonalAntibodies, NeutralizingBiological ProductsImmunoglobulin AImmunoglobulin GADAimmunogenicityisotypingLC-MSmonoclonal antibody

Identifiers

PMID33404777
PMCPMC7788027
OpenAlexW3120970607

What OpenQuestion holds

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Registered trials

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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.