综合复合沉和分散微固态相提取平台,用于治疗单克隆抗体中非挥发性化合物的非向查
Yangguo Xie1, Ying Cheng1, Wei Hou1
1Analytical Science and Development, Henlius Biologics Co., Ltd, 5155 Guangfulin Road, Shanghai, 201616, China.
Talanta
|March 15, 2026
概括
一种新方法通过消除干扰来增强单克隆抗体A (Mab A) 中的非挥发性有机化合物 (NVOC) 分析. 这种综合方法提供了对治疗抗体的敏感,准确和高效的NVOC查.
科学领域:
- 分析化学 分析化学
- 生物制药学分析
背景情况:
- 治疗性单克隆抗体 (Mabs) 需要严格的质量控制.
- 在Mabs中非挥发性有机化合物 (NVOC) 的非向查面临着由矩阵干扰和低灵敏度带来的挑战.
研究的目的:
- 开发一个集成的分析平台,用于在Mab A.中进行敏感和准确的非向NVOC查.
- 为了克服矩阵干扰并满足生物制药分析中严格的灵敏度要求.
主要方法:
- 开发了一个集成的平台,结合了复合-沉和分散微固相提取 (D-μSPE).
- 酸/氨基 thiocyanate 剂被用于消除聚酸盐干扰.
- NH2-MIL-101 ((Fe) 吸附剂用于NVOC分析剂的丰富.
主要成果:
- 优化的方法实现了NVOCs (0.32-53.98μg/L) 的低检测极限.
- 证明了出色的精度 (RSD <3.9%) 和高精度 (84.2-112.8%的恢复).
- 该方法在Mab A.中对各种NVOCs小组证明是有效的.
结论:
- 开发的技术为治疗单克隆抗体中的NVOC分析提供了灵敏,高效和环保的解决方案.
- 这种综合方法提供了一种可靠的方法,用于复杂生物制药矩阵中的非向NVOC查.
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