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.