Multiple mechanisms can underlie an IRR.
Clin Exp Immunol 3:
A complete analytical assessment of ADAs includes the following steps:
Diversity and specificity of adaptive immune responses to a therapeutic may be influenced by these antibodies.
The proclivity to form NAbs might be related to two factors:
As can be seen in Table 7, the assay precision results for all PCs were within the acceptable limits as defined above.
Four human serum lots were identified as outliers during CP analysis for each assay method.
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