Table 1

Immunogenicity assay characteristics

Drug Tolerance


Assay

Assay Sensitivity*

LLRD

Anti-panitumumab

Panitumumab


ELISA

10 ng/mL

60 ng/mL

60 ng/mL

500 ng/mL

9 μg/mL

81 μg/mL

Biacore

1.8 μg/mL

1.8 μg/mL

4 μg/mL

20 μg/mL

1.9 μg/mL

7.8 μg/mL

Bioassay

~62.5 ng/mL

~125 ng/mL

~1 μg/mL

~2.5 μg/mL


*Intersection of the assay threshold with the rabbit polyclonal anti-panitumumab antibody dose-response curve.

Level of anti-panitumumab antibodies that can be detected in the presence of the amount of panitumumab in the adjacent column.

LLRD, lower limit of reliable detection, the lowest concentration of the rabbit polyclonal anti-panitumumab antibody that could be reliably detected as positive when spiked into neat serum from multiple donors.

Weeraratne et al. BMC Clinical Pharmacology 2011 11:17   doi:10.1186/1472-6904-11-17

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