Characterization Of Protein Impurities / Degradants By Mass Spectrometry

Summary: Characterization of Active Pharmaceutical Ingredients (API) and drug product impurity profiles aided by degradation studies and/or stability studies is one of the most important aspects during drug development in assuring the safety and efficacy of a therapeutic ingredient. While this can be a significant task even for small molecules, the task can be much more challenging for proteins, and other biologics (large molecules), growing proportionally with the size of the molecule. This requires careful planning of characterization efforts, and often there is a need for an iterative approach, since early characterization work is critical to developing a systematic study of the primary degradation pathways particular to a given protein material.

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