mAbs (Dec 2025)

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,
  • Valentin Stanev,
  • Maryam Pouryahya,
  • Mehdi Boroumand,
  • Jenna Caldwell,
  • Alison Hinton,
  • Madison Kreitz,
  • Mitali Shah,
  • Austin Gallegos,
  • Neil Mody,
  • Pin-Kuang Lai

DOI
https://doi.org/10.1080/19420862.2025.2483944
Journal volume & issue
Vol. 17, no. 1

Abstract

Read online

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.

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