Pöhler Alexander, Wessels Uwe, Staack Roland F, Nordgren Maria, Lood Rolf, Stubenrauch Kay-Gunnar
Roche Pharma Research & Early Development (pRED), Pharmaceutical Sciences, Bioanalysis & Biomarkers, Roche Innovation Center Munich, Roche Diagnostics GmbH, Nonnenwald 2, 82377, Penzberg, Germany.
Genovis AB, Karl Johans väg 104, SE-244 21, Kävlinge, Sweden.
AAPS J. 2025 Apr 11;27(3):76. doi: 10.1208/s12248-025-01067-0.
IgM-selective proteolytic cleavage can become a groundbreaking tool for immunoassay-based bioanalysis. We tested the utility of a newly introduced IgM-selective protease in three different bioanalytical applications and showed that protease treatment can eliminate rheumatoid factor interference and simplify IgM isotyping. Surprisingly, we discovered that a gene therapy-induced immune response was underestimated in an anti-capsid IgG assay when treatment-emergent IgM were present in the matrix. Selective IgM digestion eliminated this interference.
IgM 选择性蛋白水解切割可成为基于免疫分析的生物分析的开创性工具。我们在三种不同的生物分析应用中测试了新引入的 IgM 选择性蛋白酶的效用，结果表明蛋白酶处理可消除类风湿因子干扰并简化 IgM 分型。令人惊讶的是，我们发现当基质中存在治疗诱导产生的 IgM 时，抗衣壳 IgG 检测低估了基因治疗诱导的免疫反应。选择性 IgM 消化消除了这种干扰。
