U/HPLC Analytical/Semi-preparative

SEC, IEC, HILIC, HIC, RP-HPLC with UD/PDA/FLD/ELSD Detection;
Size variants, charge variants, glycan profiling, surfactant, process impurities, etc.
Enrichment and fractionation of minor product variants for characterization and activity determination

Capillary Electrophoresis

Fragments: CE-SDS, CE-LIF & CZE;
Charge Variants and pI values: icIEF & IEX

2-D Electrophoresis

2D SDS-PAGE、2D-DIGE
Determination of HCP Population, identification and coverage of HCP antibodies in the ELISA kits

Biological Analysis/Affinity Determination

30+ antigens and anti-drug Abs for popular drug targets;
Bioassay cell lines: 40+ tumor cells, 3-tier cell banking system;
Primary functions: direct binding, competition binding, cell inhibition and direct killing activities;
Fc effector functions: C1q, ADCC, CDC & FcRn

LC-MS/MS Product Characterization

Mw, Peptide Map, Disulfide Isoforms, Glycan profiling;
Determination of product variants and degradation hot spots