Fully automated turbidity measurements of mAbs with Junior VIS

Význam tématu

Accurate turbidity measurement is crucial for evaluating stability of monoclonal antibody formulations. This parameter informs on aggregation and clarity, guiding development of safe and effective therapeutic proteins.

Cíle a přehled studie

The study compares a fully automated visual inspection station with a conventional Hach Lange 2100 AN turbidimeter. Five monoclonal antibody formulations were analyzed to assess result equivalence and operational efficiency.

Použitá metodika a instrumentace

Manual measurements on the Hach Lange 2100 AN followed the manufacturer guidelines with three replicate readings per vial position, reporting the lowest value. Automated analysis on Junior Visual Inspection Station involved loading samples and standards onto the platform for sequential measurement of turbidity, particle counting and color assessment. Each sample was measured in five replicates.

Instruments used

• Unchained Labs Junior Visual Inspection Station Automated system allowing vial rotation and unattended measurements
• Hach Lange 2100 AN turbidimeter Standard manual nephelometric measurement requiring sample cuvettes

Hlavní výsledky a diskuse

Both systems yielded comparable turbidity values across all five formulations, with the automated station showing slightly higher but correlating results. Replicate data demonstrated high precision for the automated workflow. The automated station processed up to 260 samples with minimal setup and delivered consistent results comparable to manual analysis.

Přínosy a praktické využití metody

• Reduction of operator hands on time by approximately 45 fold when analyzing large sample sets
• High throughput capability enabling hundreds of measurements per day
• Integrated assessment of turbidity, visible particles and color in one automated sequence
• Enhanced reproducibility and minimized risk of cuvette handling errors

Budoucí trendy a možnosti využití

Automation of solution stability assays is expected to expand through integration with additional analytical modules such as pH, viscosity and mass spectrometry. Adoption of advanced robotics and data analytics may further accelerate formulation development and quality control workflows.

Závěr

The automated visual inspection station matches the performance of a traditional turbidimeter while substantially cutting hands on time. Its high throughput and multifunction capability make it a powerful tool for rapid screening of biopharmaceutical formulations.