Protein glycosylation can impact the efficacy, safety, and pharmacokinetics of therapeutic proteins. Achieving uniform and consistent protein glycosylation is an important requirement for product quality control at all stages of therapeutic protein drug discovery and development. The development of a new microfluidic CE device compatible with MS offers a fast and sensitive orthogonal mode of high‐resolution separation with MS characterization. Here, we describe a fast and robust chip‐based CE‐MS method for intact glycosylation fingerprinting of a therapeutic fusion protein with complex sialylated N and O‐linked glycoforms. The method effectively separates multiple sialylated glycoforms and offers a rapid detection of changes in glycosylation profile in 6 min.

中文翻译：

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通过基于微流控芯片的毛细管电泳-质谱法对高度糖基化融合蛋白进行快速指纹识别

蛋白质糖基化会影响治疗性蛋白质的功效、安全性和药代动力学。实现均匀一致的蛋白质糖基化是治疗性蛋白质药物发现和开发各个阶段产品质量控制的重要要求。与 MS 兼容的新型微流体 CE 设备的开发提供了一种快速、灵敏的正交模式的高分辨率分离和 MS 表征。在这里，我们描述了一种快速且稳健的基于芯片的 CE-MS 方法，用于对具有复杂唾液酸化 N 和 O 连接糖型的治疗性融合蛋白进行完整糖基化指纹图谱分析。该方法可有效分离多种唾液酸化糖型，并在 6 分钟内快速检测糖基化谱的变化。