期刊
BIOANALYSIS
卷 10, 期 11, 页码 803-814出版社
FUTURE SCI LTD
DOI: 10.4155/bio-2018-0047
关键词
antidrug antibody; aqueous humor; drug tolerance; ELISA; immune complex assay; immunogenicity; ophthalmology; safety assessment; vitreous humor
Aim: High drug concentrations in ocular fluids after intravitreal administration preclude the use of drugsensitive 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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