Late Stage Development


Late Stage Development

Following the Journey of the Molecule, it's in Late Stage Development where pharmaceutical products go through rigourous characterization analyses.

Large molecule therapies need to be fully understood at the intact protein, peptide, and glycan levels, requiring multiple stages of characterization analysis.

Small molecule drugs are subjected to robust method development processes to the identify information-rich and reliable analytical methods – from forced degradation studies and impurity profiles, to stability testing, route optimization, and formulation development – that will define the final product's critical quality attributes.

  • Biopharmaceutical Characterization — From UPLC/MS/MS and HDX MS for advanced characterization, to UPLC/UV for routine bioseparations, our solutions have been purposefully built for the needs of biotherapeutics.
  • Method Development — We provide a full range of chromatographic selectivity choices to complement the speed, sensitivity, and resolution of UPLC, which is paired with the industry's leading processing and reporting capabilities in regulatory-ready Empower Software.

 

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