Subathra Ramamoorthy, Veranova, on how forced degradation and trace impurity profiling in potent APIs shape regulator-ready analytical methods.
|Articles|July 15, 2013
- Pharmaceutical Technology-07-15-2013
- Volume 2013 eBook
- Issue 1
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.
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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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