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Assay format of immunogenicity assay


Two assay formats can be offered

Case study 1: immunogenicity test of TDM-1 in cynomolgus monkey

Cynomolgus monkey, iv dosed with 1 mg/kg TDM-1 on day 0, day 21, day42, day 63.

  • ADA tested using screening assay, confirmatory assay ( confirmed by both Trastuzumab, and TDM-1) and titer assay
  • ADA occurred in one animal after repeated IV dosing

Case study 2: Immunogenicity test of anti-PD-L1 in SD rat


Dynamic cut point of screening assay: 0.055 for rat#2 plate, 0.056 for rat#3 plate

  • ADA occurred from day 4 of both animals
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