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Nanoplasmonic Avidity-Based Detection and Quantification of IgG Aggregates
Thuy Tran1, Erik Martinsson2, Sergio Vargas3
1Laboratory of Molecular Materials, Division of Biophysics and Bioengineering, Department of Physics, Chemistry and Biology, Linköping University, Linköping 581 83, Sweden.
Analytical Chemistry
|November 1, 2022
Summary
A novel biosensor rapidly detects and quantifies therapeutic monoclonal antibody (mAb) aggregates using Protein A avidity. This technology enables faster quality control and potential in-line monitoring for improved biopharmaceutical production.
Area of Science:
- Biotechnology
- Analytical Chemistry
- Pharmaceutical Science
Background:
- Therapeutic monoclonal antibody (mAb) production requires rigorous quality control.
- Antibody aggregation is a common issue, impacting drug efficacy and safety.
- Existing methods for aggregate detection are often slow and challenging.
Purpose of the Study:
- To develop a rapid, label-free biosensor for detecting and quantifying mAb aggregates.
- To utilize Protein A avidity effects for specific aggregate detection.
- To enable faster at-line and potential in-line quality control of mAb therapeutics.
Main Methods:
- A fiber optical nanoplasmonic biosensor system was employed.
- Protein A-functionalized sensor chips were used to detect immunoglobulin G (IgG) aggregates.
- Avidity effects at specific pH (3.8-4.0) were exploited to differentiate aggregates from monomers.
- Neural network-based curve fitting was used for simultaneous quantification.
Main Results:
- The biosensor demonstrated specific detection and quantification of IgG aggregates.
- Significantly different binding and dissociation kinetics were observed between aggregates and monomers.
- A limit of detection (LOD) of approximately 9 μg/mL and a limit of quantification (LOQ) of 30 μg/mL were achieved.
- Simultaneous quantification of monomers and aggregates was possible at low concentrations.
Conclusions:
- The developed avidity-based biosensor offers a rapid and reliable method for mAb aggregate analysis.
- This technology facilitates at-line quality control and lot/batch release testing.
- The system holds potential for real-time in-line monitoring, process intensification, and automation in biopharmaceutical manufacturing.
