Formation of aggregates during production of IgG is a constantly recurring problem which requires additional purification steps and off-line analysis. However, it is very important to remove these from the end-product since aggregates can induce a different therapeutic response compared to monomeric IgGs.
ArgusEye are developing an in-line sensor that can detect and quantify the amount of aggregates present in the sample directly during the purification procedure. Real-time quantification of aggregates can significantly reduce time needed for off-line analysis and provide direct information about the need for further processing steps.
In the experiment below, we compared five different IgG samples with aggregates ranging from 1 to 20%. In the UV-signal, no difference can be seen for the different samples but with a sensor from ArgusEye it is possible to detect and differentiate samples with different aggregate levels.
- Aggregate levels in the elution pool can be measured in real-time
- Lower aggregate levels (<1%) can be determined if higher load is used