Biochemical and Biosimilar Characterization

Biochemical and Biosimilar Characterization 2017-01-13T19:30:42+00:00

ICH Q6B guidelines [3] specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity, immunochemical properties) by appropriate techniques.  SSCI provides full range of support services to determine the purity, identity, and potency of biological products and biosimilars including but not limited to protein, peptide, and oligonucleotide based drug substance or drug product.

  • Identity:  Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, Ultra High Resolution Q-TOF), NMR (1D and 2D), IR, Raman, UV-Vis, protein sequence & composition
  • Purity and impurity:  LC (Reversed-phase, ion exchange, and size exclusion) Electrophoresis (Native/SDS-PAGE, isoelectric focusing)
  • Potency:  Ligand binding assay and functional assay