Identification and Quantification of Trace-Level Protein Impurities

The authors discuss the development of a simple, sensitive, and universal platform for identification and quantification of trace-level protein impurities in biotherapeutics. IgG monoclonal antibody spiked with low abundant proteins was used as the model to test the assay sensitivity and dynamic range. The simultaneous qualitative and quantitative analysis of low abundance proteins was achieved with single injection on a hybrid quadrupole-Orbitrap mass spectrometer.

This LC–MS based approach can be applied for host-cell proteins generated during drug process development by recombinant DNA technology.

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