Limited proteolysis and peptide mapping for comparability of biopharmaceuticals: An evaluation of repeatability, intra-assay precision and capability to detect structural change

- Limited proteolysis used for the comparability of a biopharmaceutical.
- Method was applied to samples which with altered higher order structures.
- Resulting peptide maps were found to be significantly different to control samples.
- Repeatability and intra-assay variation of the method were assessed.