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        Complete analytical development packages with mAb/ADC harmonization
        • Concentration determination: Spectrophotography
        • Endotoxin level determination: LAL method
        • Drug to Antibody ration (DAR) determination: UV-Vis, LC-MS, HPLC-HIC, iCIEF, etc.
        • Purity determination: SEC/ RP/ HIC-HPLC, SDS-PAGE, etc.
        • Residues of free drug determination: LC-MS/MS
        • Residues of solvent determination: GC
        • Site mapping determination: LC-MS
        • Sterility test: Membrane filtration/Direct inoculation
        LC-MS analysis for DAR determination
        Correlation of DAR determined by LC-MS and UV 252/280nm
        Peptide Mapping Analysis

        ADC/Antibody Isoelectric points analysis by iCIEF

        ADC/Antibody purity analysis by HPLC

        Bioassay implementation
        • Antigen binding activity determination: ELISA, FACS, Biacore
        • In vitro efficacy and bioactivity determination: Cytotoxicity assay, internalization assay, etc.
        • Antigen binding activity determination: ELISA, FACS

        Well established method to detect antigen binding activity for ADC/Antibody by ELISA and FACS


        ADC retained similar antigen binding activity as the original unconjugated antibody against target positive cells by FACS (right figure) and against target protein by ELISA (left figure)

        • In vitro efficacy and bioactivity determination: Cytotoxicity assay, internalization assay, etc.
        Well established method to detect antibody/ADC internalization with different targets and cell lines
        Well established method to detect antibody/ADC in vitor potency with cytotoxicity assay
        ADC release and stability testing
        (Include but not limited to the assay below)
        • Antigen binding activity determination: ELISA, FACS
        • Drug to Antibody ration (DAR) determination: UV-Vis, LC-MS, HPLC-HIC, iCIEF, etc.
        • Residues of free drug determination: LC-MS/MS
        • In vitro efficacy and bioactivity determination: Cytotoxicity assay
        Pharmacology, PK/PD & Exploratory Toxicity
        • Mouse, rat, monkey SC, IP, IV bolus, IV infusion;
        • Bio-analytical development
        • PK/PD modeling and simulation
        • In vitro stability in biological matrices
        • Single dose, repeated dose, dose range finding in rat and monkeys
        • Efficacy Studies
        • 160+ cell line xenografts and 270+ PDXs (patient derived xenografts)
        • Biodistribution
        • Imaging with labeled mAb or ADC
        • Ex vivo tissue concentration analysis

        In vivo efficacy study with target positive xenograft model


        Full regression of tumor after treatment with ADC but not unconjugated antibody with same treatment yield.

        Case study on T-DM1 (Kadcyla?)

        As a case study, Herceptin-DM1 (T-DM1; Kadcyla?) was synthesized by our scientists and potency was tested by in vitro proliferation assay and by in vivo xenograft model.

        Synthetic T-DM1 shows full biological activity and in vivo? PK profiles. Together with safety profile, it shows all the characteristics of the commercially available product.



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