通过大小排斥染色体对单克隆抗体的持续监测显示了系统适应性参数和柱子老化之间的相关性

Kai-Wei Wu1, Tse-Hong Chen2, Teng-Chieh Yang2

  • 1Department of Pharmaceutics and Drug Delivery, The University of Mississippi, University, MS 38677, USA.

概括

监测尺寸排除色谱 (SEC) 列对于生物产品的纯度至关重要. 在1000次注射后,尾部系数和峰值宽度等关键性能指标降低,分辨率和板数减少,影响了试验可靠性.

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