Journal of Immunology Research / 2016 / Article / Tab 2

Research Article

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

Table 2

Estimation of within monkey variability across biotherapeutics. Four types of biotherapeutics were spiked in two baseline samples taken 1 week apart from 15 cynomolgus monkeys and tested in the assay. The background data from the biotherapeutic spiked samples showed that within monkey signal variability was similar. Therefore, the overall variability obtained with these four molecules could be used to estimate a generic cut point factor.

BiotherapeuticType of moleculeEstimated within monkey SD

ADC CADC0.095
mAb 1One-arm mAb0.086
mAb 2IgG1 mAb0.096
mAb 4IgG4 mAb0.087
Overall0.091

SD = estimate of within monkey signal variability.

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