Product Characterization

Structural Analysis

• Spectroscopy: CD (Near/Far UV), Fluorescence, DSC
• Aggregation/Degradation: SDS-PAGE, CE-SDS, SEC, CEX-HPLC, cIEF
• Sequence & Identification: Mass analysis, peptide mapping, disulfide linkage, modifications, oxidation, truncations
• Glycan Analysis: NP-HPLC (HILIC), intact mass

Functional Analysis

• Potency: Cell-based assays, cytotoxicity, neutralization, cytokine secretion, apoptosis assays, ELISA formats
• Binding Kinetics: Antigen/Fc binding, titer estimation via ELISA/SPR
• Flow Cytometry: Cell analysis, receptor quantification
• Purity Testing: Residual DNA, protein A, HCP

Our integrated approach ensures robust physiochemical, efficacy, binding, safety,and higher- order analysis to support regulatory compliance and successful product development.