Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection

被引：17
|
作者：
Wessels, Uwe [1 ]
Zadak, Markus [1 ]
Reiser, Astrid [1 ]
Brockhaus, Janis [2 ]
Ritter, Mirko [2 ]
Abdolzade-Bavil, Afsaneh [1 ]
Heinrich, Julia [1 ]
Stubenrauch, Kay [1 ]
机构：
[1] Roche Innovat Ctr Munich, Pharma Res & Early Dev, Pharmaceut Sci, Nonnenwald 2, D-82377 Penzberg, Germany
[2] Roche Diagnost GmbH, Roche Innovat Ctr Munich, Nonnenwald 2, D-82377 Penzberg, Germany
来源：
BIOANALYSIS | 2018年 / 10卷 / 11期
关键词：
antidrug antibody; aqueous humor; drug tolerance; ELISA; immune complex assay; immunogenicity; ophthalmology; safety assessment; vitreous humor; DRUG TOLERANCE; BIOTECHNOLOGY PRODUCTS; MACULAR DEGENERATION; TARGET INTERFERENCE; VITREOUS-HUMOR; SERUM SAMPLES; ASSAYS; RECOMMENDATIONS; PHARMACOKINETICS; RANIBIZUMAB;
D O I：
10.4155/bio-2018-0047
中图分类号：
Q5 [生物化学];
学科分类号：
071010 ; 081704 ;
摘要：
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.
引用
收藏
页码：803 / 814
页数：12
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