Evidence map›Paper›PMID 40170162›Full record

ArticlemAbs2025

Accelerating high-concentration monoclonal antibody development with large-scale viscosity data and ensemble deep learning.

Lateefat A Kalejaye, Jia-Min Chu, I-En Wu, Bismark Amofah, Amber Lee, Mark Hutchinson, Chacko Chakiath, Andrew Dippel, Gilad Kaplan, Melissa Damschroder and 10 more

Abstract read
In one paragraph

Article in mAbs, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
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

13 citing papers in PubMed.

  1. Article
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  7. Review
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  9. Fab-Fc and Fab-Fab interactions of variable strength and valency contribute to the high concentration viscosity of IgGProceedings of the National Academy of Sciences of the United States of America · 2026
    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

20 authors.

Lateefat A KalejayeDepartment of Chemical Engineering and Materials Science, Stevens Institute of Technology, Hoboken, NJ, USA.ORCID 0000-0001-7421-6515
Jia-Min ChuDepartment of Chemical Engineering and Materials Science, Stevens Institute of Technology, Hoboken, NJ, USA.
I-En WuDepartment of Chemical Engineering and Materials Science, Stevens Institute of Technology, Hoboken, NJ, USA.ORCID 0009-0009-2108-7436
Bismark AmofahBiologics Engineering, R&D, AstraZeneca, Gaithersburg, MD, USA.
Amber LeeBiologics Engineering, R&D, AstraZeneca, Gaithersburg, MD, USA.
Mark HutchinsonBiologics Engineering, R&D, AstraZeneca, Gaithersburg, MD, USA.
Chacko ChakiathBiologics Engineering, R&D, AstraZeneca, Gaithersburg, MD, USA.
Andrew DippelBiologics Engineering, R&D, AstraZeneca, Gaithersburg, MD, USA.
Gilad KaplanBiologics Engineering, R&D, AstraZeneca, Gaithersburg, MD, USA.
Melissa DamschroderBiologics Engineering, R&D, AstraZeneca, Gaithersburg, MD, USA.
Valentin StanevData Science and Modelling, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Maryam PouryahyaData Science and Modelling, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Mehdi BoroumandData Science and Modelling, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Jenna CaldwellDosage Form Design and Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Alison HintonDosage Form Design and Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Madison KreitzDosage Form Design and Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Mitali ShahDosage Form Design and Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Austin GallegosDosage Form Design and Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Neil ModyDosage Form Design and Development, BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, MD, USA.
Pin-Kuang LaiDepartment of Chemical Engineering and Materials Science, Stevens Institute of Technology, Hoboken, NJ, USA.ORCID 0000-0003-2894-3900

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Highly concentrated antibody solutions are necessary for developing subcutaneous injections but often exhibit high viscosities, posing challenges in antibody-drug development, manufacturing, and administration. Previous computational models were only limited to a few dozen data points for training, a bottleneck for generalizability. In this study, we measured the viscosity of a panel of 229 monoclonal antibodies (mAbs) to develop predictive models for high concentration mAb screening. We developed DeepViscosity, consisting of 102 ensemble artificial neural network models to classify low-viscosity (≤20 cP) and high-viscosity (>20 cP) mAbs at 150 mg/mL, using 30 features from a sequence-based DeepSP model. Two independent test sets, comprising 16 and 38 mAbs with known experimental viscosity, were used to assess DeepViscosity's generalizability. The model exhibited an accuracy of 87.5% and 89.5% on both test sets, respectively, surpassing other predictive methods. DeepViscosity will facilitate early-stage antibody development to select low-viscosity antibodies for improved manufacturability and formulation properties, critical for subcutaneous drug delivery. The webserver-based application can be freely accessed via https://devpred.onrender.com/DeepViscosity.

Indexed as

Antibodies, MonoclonalDeep LearningDrug DevelopmentHumansNeural Networks, ComputerViscosityAntibodies, MonoclonalAntibody viscosityensemble deep learninghigh-concentration formulationsmonoclonal antibodies

Identifiers

PMID40170162
PMCPMC12128653

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.