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对临床使用的人类白蛋白制剂的纯度进行比较分析

Liye Maeyama¹, Stefanie Fas¹, Jörg Schüttrumpf¹

¹Biotest AG, Landsteinerstraße 5, D-63303, Dreieich, Germany.

Analytica chimica acta

|November 23, 2024

概括

商用人体白蛋白制剂符合药典标准. 然而,核磁共振 (NMR) 分析揭示了供应商之间的微妙纯度差异,影响生物产品质量.

科学领域:

生物化学生物化学
分析化学分析化学
药理学药理学是指药理学的学科.

背景情况:

专是一种具有重要生理功能的关键血蛋白.
专缺乏与各种疾病有关,专替代可以改善患者的治疗结果.
临床白蛋白是通过分化从人体血中提取的,其生产优化了纯度.

研究的目的:

评估商业化人类白蛋白制剂的质量.
研究核磁共振 (NMR) 对于分析生物产品的实用性.
为了确定不同制造商的白蛋白产品之间纯度的潜在差异.

主要方法:

使用药典测定方法分析商业人体白蛋白.
1H NMR和13C-HSQC的应用用于身份确认.
利用T2过的1H NMR和13C-HSQC来检测和描述小分子并评估纯度.

主要成果:

所有测试的白蛋白制剂都符合国际药典对,乙醇,和蛋白质聚合物等参数的要求.
在所有供应商中,NMR证实了专素制剂的同一性.
分析显示,白蛋白产品的纯度存在差异,非白蛋白成分的含量也存在差异.

结论:

商用白蛋白产品符合既定的质量标准.
核磁共振光谱为评估生物治疗药物的身份和纯度提供了先进的能力.
尽管生产标准化,但白蛋白纯度存在差异,需要进一步调查其临床相关性.

关键词:

人类血清专素的人类血清专素核磁共振光谱法 (NMR) 是一种光谱法.纯度纯度是一个纯度.通过T(2) 过的NMR.

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