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Ultra-Dilute Developability Analysis of Antibody Self-Association and Non-Specific Binding
Na-Young Kwon1, Murat Karadag1, Peter M Tessier2
1Departments of Pharmaceutical Sciences and Chemical Engineering, Biointerfaces Institute, University of Michigan, Ann Arbor, MI, USA.
Methods in Molecular Biology (Clifton, N.J.)
|May 13, 2026
Summary
New assays assess monoclonal antibody (mAb) developability by measuring self-association and non-specific binding at ultra-dilute concentrations. These methods help identify promising antibody candidates early in development, reducing risks associated with poor biophysical properties.
Area of Science:
- Biochemistry
- Biotechnology
- Pharmaceutical Science
Background:
- Early-stage screening of antibody developability is crucial for identifying successful monoclonal antibody (mAb) candidates.
- Challenges include large candidate numbers and limited quantities, concentrations, and purities.
- Assessing biophysical properties alongside biological activity is essential.
Purpose of the Study:
- To develop and validate methods for assessing mAb developability at ultra-dilute concentrations (~0.01-0.05 mg/ml).
- To evaluate self-association and non-specific binding properties of mAbs.
- To enable early identification of mAb candidates with reduced development risks.
Main Methods:
- Self-association measured using AC-SINS (physiological conditions) and CS-SINS (formulation conditions) assays.
- Non-specific binding measured using the PSP assay with Protein A-functionalized magnetic beads and flow cytometry.
- Both assays capture mAbs on functionalized surfaces and evaluate specific interactions or properties.
Main Results:
- Developed assays capable of assessing mAb self-association and non-specific binding at ultra-dilute concentrations.
- Demonstrated utility of AC-SINS, CS-SINS, and PSP assays for mAb developability screening.
- These methods allow for the identification of mAbs with lower risk of development challenges.
Conclusions:
- The AC-SINS, CS-SINS, and PSP assays provide a robust framework for early-stage mAb developability assessment.
- These methods facilitate the selection of mAb candidates with favorable biophysical properties.
- Early identification of developability issues mitigates risks like poor solubility, high viscosity, or rapid clearance.
