开发和验证一种无标签的HPLC-CAD方法,以确定治疗性蛋白质中总酸的含量
Yifei Wang1, Yuechuan Alex Xu1, Björn-Hendrik Peters1
1Drug Product Development, Bristol Myers Squibb, 1 Squibb Drive, New Brunswick, NJ 08901, USA.
概括
一种新的无标签HPLC方法准确地测量了蛋白质药物的总酸. 这种高效的技术简化了治疗性蛋白质产品的化分析.
科学领域:
- 生物化学 生物化学
- 分析化学 分析化学
- 制药科学 制药科学
背景情况:
- 化显著影响治疗蛋白质的特性,包括药理动力学和免疫性.
- 精确监测酸水平对于蛋白质制药的质量控制至关重要.
研究的目的:
- 开发和验证一种新的,无标签的高性能液体染色学 (HPLC) 方法,用于量化蛋白质药物产品中的总酸.
- 建立一个强大的和有效的分析方法来评估蛋白质化.
主要方法:
- 一个可更换的,列前C18弹被用于线内蛋白质的去除,防止干扰和列污染.
- 使用了具有挥发性移动相的优化混合模式水友互动离子交换液体色谱 (HILIC-IEX).
- 充电式气溶检测 (CAD) 用于对酸的敏感检测.
主要成果:
- 该方法表现出极好的线性 (R > 0.999),精度 (RSD 0.42.1%),灵敏度 (QL < 25 ng) 和准确性 (93102%的恢复).
- 具体性是令人满意的,该方法已成功应用于一个模型蛋白质药物产品.
- 开发的HPLC方法被证明是准确的,坚固的,高效的和具有成本效益的.
结论:
- 新的无标签HPLC方法为蛋白质药物产品中总酸分析提供了可靠的工具.
- 这种方法为药品质量控制中的常规化评估提供了一个有希望的解决方案.
- 该方法的效率和成本效益使其适合在生物制药分析中广泛应用.
相关概念视频
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