Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection.

Published on Apr 11, 2018in Bioanalysis2.371
· DOI :10.4155/BIO-2018-0047
Uwe Wessels7
Estimated H-index: 7
(Hoffmann-La Roche),
Markus Zadak3
Estimated H-index: 3
(Hoffmann-La Roche)
+ 5 AuthorsKay Stubenrauch16
Estimated H-index: 16
(Hoffmann-La Roche)
Sources
Abstract
Aim: High drug concentrations in ocular fluids after intravitreal administration preclude the use of drug-sensitive immunoassays. A drug-tolerant immunoassay is therefore desirable for immunogenicity testing in ophthalmology. Experimental: Immune complex (IC) antidrug antibody (ADA) assays were established for two species. The assays were compared with the bridging assay in ocular and plasma samples from two preclinical studies. Results: The IC assays showed high drug tolerance, which enabled a reliable ADA detection in ocular fluids after intravitreal administration. The IC assays were superior to the bridging assay in the analysis of ocular fluids with high drug concentrations. Conclusion: The IC assay allows a reliable ADA detection in matrices with high drug concentrations, such as ocular fluids.
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