应用成像毛细管等电聚焦（icIEF）分析治疗性单克隆抗体。
Analysis of therapeutic monoclonal antibodies by imaged capillary isoelectric focusing (icIEF).
机构信息
Tanvex Biopharma USA, Inc., 10394 Pacific Center Ct, San Diego, CA 92121, USA.
出版信息
Anal Methods. 2024 Aug 8;16(31):5450-5458. doi: 10.1039/d4ay00836g.
Imaged capillary isoelectric focusing (icIEF) is a preferred analytical method for determining isoelectric points (pIs) and charge heterogeneity profiles in biotherapeutic proteins. In this study, we optimized the icIEF method for an in-house IgG1κ monoclonal antibody (mAb-1) and assessed its reproducibility, robustness, and autosampler stability. The optimized method was used to evaluate batch-to-batch consistency in pIs for multiple lots of mAb-1 and determine the relative percentages of charge variants. We also tested the method's performance using multiple lots of another IgG1 mAb, commercially available as Herceptin (trastuzumab). Additionally, we designed and assessed native and denaturing platform icIEF methods for 11 other marketed mAbs, with pIs ranging from 6.0 (eculizumab) to 9.22 (tocilizumab).
成像毛细管等电聚焦（icIEF）是一种用于确定治疗性生物蛋白等电点（pI）和电荷异质性分布的首选分析方法。在这项研究中，我们对内部 IgG1κ 单克隆抗体（mAb-1）进行了 icIEF 方法的优化，并评估了其重现性、稳健性和自动进样器稳定性。该优化方法用于评估多个批次 mAb-1 的 pI 批间一致性，并确定电荷变异体的相对百分比。我们还使用多个批次的另一种 IgG1 单克隆抗体（作为赫赛汀（曲妥珠单抗）商业化）测试了该方法的性能。此外，我们还设计和评估了 11 种其他市售 mAb 的天然和变性平台 icIEF 方法，pI 范围从 6.0（eculizumab）到 9.22（tocilizumab）。
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