Fully automated turbidity measurements of mAbs with Junior VIS

Significance of the Topic

Protein aggregation and cloudiness in monoclonal antibody formulations can compromise safety and efficacy in biopharmaceutical development.
Routine turbidity measurements guide stability assessment but require laborious manual handling.
Automation of these measurements supports high-throughput screening and reduces operator variability.

Objectives and Study Overview

This study compares fully automated turbidity measurement on the Junior VIS platform to a conventional manual method using the Hach Lange 2100 AN turbidimeter.
Five monoclonal antibody formulations in development are analyzed to evaluate measurement accuracy, precision, and operator time savings.

Methodology and Instrumentation

Manual turbidity analysis: three replicate measurements per vial position on the Hach Lange 2100 AN with the lowest value reported.
Automated analysis: the VIS system calibrates, transfers each vial, rotates it by 90°, and records turbidity over five replicates before averaging.

Used Instrumentation

• Unchained Labs Junior VIS visual inspection station
• Hach Lange 2100 AN turbidimeter

Main Results and Discussion

Both methods produced comparable turbidity values for all five formulations, with VIS measurements slightly higher but within acceptable precision (RSD 2–5%).
The VIS demonstrated consistent repeatability across replicates, confirming data reliability.
Time comparison:

• VIS: ~2 minutes per sample (including vial handling), fully unattended after setup
• Hach Lange: ~3.5 minutes per sample, requiring manual transfer and cell cleaning

Processing 260 samples:

• Hach Lange: ~15 hours of hands-on operation
• Junior VIS: 20-minute setup and ~8.7 hours total automated run time (45-fold operator time reduction)

Benefits and Practical Applications

Automated turbidity measurement accelerates formulation screening with minimal manual labor.
Simultaneous particle counting and color assessment enable multi-attribute quality control in a single workflow.
Integration with pH and viscosity modules supports comprehensive formulation characterization.

Future Trends and Potential Applications

Expansion of automated platforms to include spectral and morphological analyses for deeper formulation insights.
Integration with laboratory information management systems (LIMS) and artificial intelligence for predictive stability modeling.
Scalable workflows in larger systems (e.g., Big Kahuna) to accommodate increasing sample volumes in bioprocess development.

Conclusion

The Junior VIS delivers turbidity results equivalent to a standard turbidimeter while significantly reducing operator involvement and throughput time.
Implementing such automation enhances laboratory efficiency and supports rapid antibody formulation development.