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

页码：803 / 814

页数：12

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