免疫原性
Immunogenicity testing for biologics, built on a tiered assay strategy. Screening, confirmatory and titer assays plus neutralizing antibody methods are developed and validated to regulatory expectations, with cut-point analysis handled properly rather than assumed.
概述
We evaluate drug immunogenicity and its impact on PK and PD by measuring ADA levels with a tiered approach (screening assay followed by a confirmatory assay).
ADA Bioanalysis for Anti-HER2 Immunogenicity Assessment
ADA tested using screening assay, confirmatory assay and titer assay
ADA occurred in one animal after repeated IV dosing
