Home
>
References
>
2010
>
Impact of matrix-associated soluble factors on the specificity of the immunogenicity assessment.
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
|
|
Species
|
|
|
|
Analytes Measured
|
|
|
|
Matrix Tested
|
|
Serum
|
Abstract
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.
View Publications
Browse Our Products
Customer Service/Orders
Scientific/Technical Support
Instrument Support
Company Headquarters