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.
|Biotherapeutic||Type of molecule||Estimated within monkey SD|
|mAb 1||One-arm mAb||0.086|
|mAb 2||IgG1 mAb||0.096|
|mAb 4||IgG4 mAb||0.087|
|SD = estimate of within monkey signal variability.|