免疫原性
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