ICH Q6B guidelines specify the characterization of a biotechnological or biological product (which includes the determination of physicochemical properties, purity and impurities, biological activity and immunochemical properties) by appropriate techniques.
We provide a complete suite of support services to determine the purity, identity and potency of biological products and biosimilars including protein, peptide and oligonucleotide-based drug substance or drug product. Our services characterize:
- Identity: Mass spectrometry (ESI-Triple Quad (QTRAP), MALDI-TOF, ultra-high resolution Q-TOF), NMR (1D and 2D), IR, Raman, UV-Vis, protein sequence and composition
- Purity and impurity: LC (reversed phase, ion exchange, and size exclusion) electrophoresis (native/SDS-PAGE, isoelectric focusing)
- Potency: Ligand binding assays and functional assays