Stability Studies

Drug substance and drug product

Stability testing and forced degradation studies of the candidate drug substance respectively drug product are mandatory for each submission and comprise an repertoire of analytical assays that are available at GlycoThera, including but not limited to
  • peptide mapping by LC-MS/MS
  • c-IEF
  • disulfide status
  • free cysteine
  • methionine oxidation
  • N- and C-terminal integrity
  • deamidation of Gln and Asn
  • CZE
  • SEC
  • protein quantification
  • RP-HPLC peptide mapping
  • N- and O-glycosylation mapping
  • monosaccharide analysis
  • CD spectroscopy
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