玻璃体内注射后眼内液中治疗性抗体的免疫原性检测。
Immunogenicity testing of therapeutic antibodies in ocular fluids after intravitreal injection.
作者信息
Wessels Uwe, Zadak Markus, Reiser Astrid, Brockhaus Janis, Ritter Mirko, Abdolzade-Bavil Afsaneh, Heinrich Julia, Stubenrauch Kay
机构信息
Pharmaceutical Sciences, Pharma Research & Early Development, Roche Innovation Center Munich, Nonnenwald 2, 82377 Penzberg, Germany.
Roche Diagnostics GmbH, Roche Innovation Center Munich, Nonnenwald 2, 82377 Penzberg, Germany.
出版信息
Bioanalysis. 2018 Jun 1;10(11):803-814. doi: 10.4155/bio-2018-0047. Epub 2018 Apr 11.
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.
目的
玻璃体内给药后眼内液中药物浓度较高，这使得药物敏感免疫测定法无法使用。因此，在眼科免疫原性检测中，需要一种耐药物免疫测定法。
实验
针对两个物种建立了免疫复合物（IC）抗药物抗体（ADA）测定法。在两项临床前研究的眼内和血浆样本中，将这些测定法与桥接测定法进行了比较。
结果
IC测定法显示出高药物耐受性，这使得在玻璃体内给药后能够在眼内液中可靠地检测ADA。在分析高药物浓度的眼内液时，IC测定法优于桥接测定法。
结论
IC测定法能够在高药物浓度的基质（如眼内液）中可靠地检测ADA。
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