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.