Impact of matrix-associated soluble factors on the specificity of the immunogenicity assessment.

Bautista, A.C., Wullner, D., Moxness, M., Swanson, S.J., Chirmule, N., Jawa, V.
Journal   Bioanalysis
Analytes Measured  
Matrix Tested   Serum
Year   2010
Volume   2
Page Numbers   721-731
Application   Immunogenicity
BACKGROUND: Specificity and sensitivity are essential in assays for immunogenicity assessment of biotherapeutics. Nonspecific interactions from excess therapeutic or anti-therapeutic antibody, soluble ligands (e.g., target receptor), or serum proteins associated with autoimmune conditions (e.g., rheumatoid factor) in samples can impact the detection of a true anti-therapeutic response.

RESULTS: Electrochemiluminescence-based bridging assay formats could eliminate the interference due to rheumatoid factor with no pretreatment with Melon Gel™ or aggregated IgG. The interference due to soluble factors was not platform specific for the four therapeutics evaluated in this study.

CONCLUSION: Melon Gel pretreatment and avidin high-bind (Meso Scale Discovery) plates can effectively reduce interference due to rheumatoid factor in ELISA- and electrochemiluminescence-based assays, respectively. Excess levels of therapeutic and anti-therapeutic antibodies in bridging assays can impact assay specificity.

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