Application of a Plug-and-Play Immunogenicity Assay in Cynomolgus Monkey Serum for ADCs at Early Stages of Drug Development

Table 3

Estimation of cut point factor based on different false positive rates (). Cut point factor (CPF) calculated at different false positive rates based on the within monkey variability observed across 4 biotherapeutics. This generic CPF can be used to establish the floating individual cut point signal according to each cynomolgus monkey baseline signal.

	Cut point factor
0.10	1.12
0.05	1.16
0.01	1.24

= false positive rate.