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Bioanalytical Assay Development

The bioanalytical assay development team holds multipleyears bioanalytical assay development experiences to support bioanalytical assay development and QC tests including HPLC, capillary electrophoresis, MS, molecularbiology and cell-based assays.

The bioanalytical analysis laboratory is designed with separate testing areas

Comprehensive sample management process to ensure stable and reliable sample preservation without being contaminated

Well established QA system to ensure operational compliance, data integrity and traceability

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

Biochemical Analysis

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

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Bioanalytical Assay Development