nuvalore centers analytics on CQAs tied to safety, efficacy, and consistency and uses fit-for-purpose techniques:

  • Drug-to-Antibody Ratio (DAR): HIC-HPLC to determine average DAR and distribution.
  • Size Variants and Purity: SEC-HPLC and CE-SDS for aggregates, fragments, and purity.
  • Charge Variants: icIEF and CEX for charge heterogeneity.
  • Identity and Primary Structure: UV-RP-HPLC peptide mapping for identity and PTM trending.
  • Free Payload and Related Impurities: Chromatographic impurity profiling to control toxicity risk.
  • GMP Quality Control Testing: USP/EP methods (appearance, color, pH, conductivity, osmolality, and visible particles) supporting batch release and ongoing quality control.
  • Glycosylation Profiling: RP-HPLC and HILIC glycan mapping for process consistency and comparability.
  • Mass Spectrometry Characterization*: Intact/subunit/native/reduced LC-MS for PTMs, DAR species, conjugation sites, and structural integrity.