The amino acid sequence of proteins is essential to its biological and physiological properties. When expressing a therapeutic protein its primary sequence is a critical quality attribute (CQA) that needs to be monitored to ensure its efficacy. In addition, there are a number of post-translational modifications such as deamidation and oxidation which are indicative of degradation. The use of tryptic digestion allows these CQAs to be monitored when they may present as too small a mass shift and to be done on the intact protein level.
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