The presence of aggregates in pharmaceutical protein/peptide products is a serious problem affecting therapeutic performance.
Advanced-detection SEC can differentiate at the molecular level between different formulations of polymeric drugs.
Aggregates can also be easily detected using this technique.
A particular example is the case of two polymeric drugs where the FDA approved and the New Synthetic Generic version were compared.
The amount of active ingredient with molecular weight range of 5-15 KDa was significantly higher in the FDA approved drug compared to the Generic one.
Figure 1. Overlay chromatogram obtained from the RI detector of FDA Approved Drug (black) and New Synthetic Generic Version (green).
The Generic version of the polymeric drug is less stable than the FDA approved version as the chromatography showed evidence of aggregation.