Protein-based therapeutics represent an increasingly significant part of the biopharmaceutical market. In order to fully characterize these novel materials, they must be analysed in both their intact form and also when fragmented into sub-units such as peptides.
Unfortunately, these proteins are typically highly heterogeneous, with many possible charge states and structural variations as well as post-translational modifications such as glycosylation or addition of other small functional groups.
Regulatory bodies such as the FDA and EMA require that these biotherapeutics are thoroughly characterized. As a result, extremely high resolution accurate mass spectrometry is required for a complete understanding of the protein structure.
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