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

Table 4

Reproducibility of the plug-and-play assay. Assay control precision expressed as the coefficient of variation of the signal observed in 6 independent runs. The negative control is a pooled cynomolgus monkey serum. The positive control is a human IgG-cynomolgus monkey IgG fusion molecule. Interassay precision for signal values obtained with the two controls is summarised below. In addition, a ratio of the signals obtained with the positive and negative controls was calculated for assay performance evaluation.

Assay control	Number of runs	Mean measurement (units)	CV (%)
Negative control	6	0.169 (AU)	16
Positive control	6	0.302 (AU)	13
		1.80 (ratio)	11

Fusion positive control at 125 ng/mL.
AU = absorbance units; CV = coefficient of variation.
Ratio = positive control signal/negative control signal.