Optimizing Downstream Control with Osmolality Testing

The bottleneck for real-time control and real-time release is the lack of product-specific in-line sensors or fast at-line methods suitable for model-based prediction of process outcome. There are multiple sensor-based parameters that help monitor a purification process, but which ones serve as predictors for protein concentration?

To answer this question, chromatography flow-through fractions were collected and analyzed for antibody concentration and osmolality, while UV280, 260, 214, pH and conductivity were measured on-line by the chromatography workstation. The root mean square error was used to assess the quality of a model-based prediction of protein quality.

This model showed that osmolality, alongside UV absorbance, is a valuable predictor for protein concentration.

Related Resources

• Resource Guide: Data and Compliance – What every lab should know
• Bioprocessing Osmometers Selection Guide
• Research Article: Osmolality is a predictor for model-based real-time monitoring of concentration in protein chromatography