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Physicochemistry Analysis

Concentration: BCA, UV(280), RP-HPLC, Titer for IPC sample

Purity and impurities measurement: size variants-SEC-HPLC, CE-SDS (reduced/non-reduced); Charge variants-IEX-HPLC, icIEF, CZE; SDS-PAGE; RP-HPLC

Identification: icIEF，Peptide mapping

Glycan analysis: N-glycan profiling and sialic acid content detection

Excipient analysis: PS80/PS20，P188

Mass Spectrometry Analysis

Intact/Reduced/Deglycosylated mass
Sequence coverage, PTMs
Free thiol
N-glycosylation site anslysis, disulfide bond analysis
N-/C- terminals sequence analysis, N-glycans ID

MOA based assays: Report gene assay, Cytotoxicityassay, cell proliferation assay
Binding assays: ELISA and Cell binding assay
Affinity measurement: SPR and BLI
Impurity monitoring: HCP/HCD/Protein A residue analysis
Copy number analysis and cDNA analysis