在生物制药中识别非挥发性有机化合物 (NVOC) 通过非目标分析和使用复合-沉提取量的量化
Feifei Luo1, Mengmeng Hao1, Lei Zhang1
1Analytical Science Development, Henlius Biologics Co., Ltd, 5155 Guangfulin Road, Shanghai 201616, China.
Journal of chromatography. A
|December 1, 2023
概括
这项研究开发了一种方法来识别和量化抗体药物中的化学漏物. 这种新方法成功地确定了7种以前未报告的化合物,有助于药物安全性评估.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 生物技术是生物技术.
背景情况:
- 生物制药制造中的一次性使用系统可能会将化学可漏物释放到药品中.
- 准确识别和量化这些可浸出物对于毒理风险评估至关重要.
- 现有的方法可能面临挑战,例如受过多酸盐等辅助剂的干扰.
研究的目的:
- 开发和验证一种全面的方法来选,识别和量化抗体药物中的非挥发性有机化合物 (NVOC).
- 为了识别以前在文献中没有报道的新型浸出物.
- 为NVOCs建立一个强大的定量方法,解决常见辅助剂带来的挑战.
主要方法:
- 使用多个数据库和质谱模拟,对23种可浸出物进行全面选和结构阐明.
- 化合物识别信心水平的分类.
- 开发一种复杂化-沉提取方法,以减轻聚酸盐干扰.
- 验证量化方法的灵敏度,准确性和精度.
主要成果:
- 确定了23种NVOC,其中包括7种以前没有报告为医疗或药品可浸物的化合物.
- 对所有已识别的化合物进行分类的置信级别.
- 成功量化了高灵敏度 (LOQ:20或50μg/L),准确度 (77.2109.5%回收率) 和精度 (RSD ≤8.2%) 的目标NVOC.
- 证明了复杂化-沉方法在减少聚酸盐干扰方面的有效性.
结论:
- 开发的分析方法使得在抗体药物中的NVOC可浸出物能够进行有效的定性和定量分析.
- 识别新型漏材料有助于更好地了解潜在的风险.
- 该方法将支持使用一次性使用系统制造的药物产品的安全性评估.
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