Stunner Biologics Characterization

Importance of the topic

Detailed protein characterization is essential in biopharma research and quality control. Integrating concentration measurement, size distribution, and aggregation analysis streamlines workflows and ensures protein integrity in development and manufacturing.

Objectives and Study Overview

This study presents the capabilities of the Stunner system, a platform designed to combine UV/Vis absorbance and dynamic light scattering on the same tiny sample to deliver comprehensive protein characterization in a single run.

Methodology and Instrumentation

• Microfluidic plate with 96 wells and two fixed optical pathlengths (0.1 mm and 0.7 mm) requiring just 2 µL per sample.


• UV/Vis spectrophotometer (230–750 nm) with xenon flash lamp source, providing high-precision absorbance over a broad dynamic range.


• Dynamic light scattering (DLS) and rotating angle DLS (RADLS) using 660 nm laser diodes to measure hydrodynamic diameter (0.3–1000 nm) and polydispersity.


• Automated workflow capable of measuring full plate absorbance in ~10 minutes and combined UV/Vis and DLS analyses within an hour.

Main Results and Discussion

• Protein quantification achieved precision within 1% and accuracy within 2% across a wide concentration range, demonstrated by an IgG dilution series with an R2 of 0.9999.


• Size and polydispersity determination yielded consistent hydrodynamic diameters (e.g., ovalbumin ~6.6 nm, thyroglobulin ~22.0 nm) with low variability.


• Aggregation detection by mass and intensity distributions allowed clear differentiation between monomers and low-level aggregates (e.g., 1% aggregate content).


• Protein–protein interaction parameters (B22 and KD) were calculated from concentration series, revealing attractive or repulsive behaviors in different buffer conditions.


• Conjugate characterization (antibody–drug and antibody–oligonucleotide) provided simultaneous determination of conjugate ratio and concentration using spectral unmixing.

Benefits and Practical Applications

• High throughput analysis with minimal sample consumption accelerates development and QC processes.


• Combined measurement modalities reduce instrument footprint and streamline data integration.


• Robotic compatibility enables unattended operation for intensive screening campaigns.

Future Trends and Opportunities

• Integration with machine learning for predictive analytics in formulation development.


• Expansion of multiplexed detection to encompass additional biophysical parameters.


• Enhanced automation and cloud connectivity for remote monitoring and data management.

Conclusion

The Stunner platform delivers a unified approach to protein characterization, combining rapid concentration measurement, size analysis, and aggregation detection in a single microfluidic workflow. This integration supports efficient research and quality control, paving the way for more streamlined biopharmaceutical operations.