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制药辅助剂三中纳米颗粒杂质诱导了早期的免疫反应

Jue Wang¹, Ying Jiang², Yang Yang¹

¹National Institutes for Food and Drug Control, National Key Laboratory for Quality Control of Pharmaceutical Excipients, Beijing, China.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

|June 24, 2023

概括

三糖辅助剂中的纳米颗粒杂质 (NPIs) 可以触发免疫反应,包括炎症和补体激活. 控制NPI对于生物产品安全至关重要,特别是在高风险的应用中.

科学领域:

免疫学免疫学免疫学
制药科学制药科学
生物技术是生物技术.

背景情况:

制药辅助剂是生物产品的关键组成部分.
从生物产品与辅助剂中区分免疫风险是具有挑战性的.
了解辅助剂相关的免疫反应对于患者的安全至关重要.

研究的目的:

为了调查与常见的制药辅助剂特雷中纳米颗粒杂质 (NPI) 相关的早期免疫风险.
用各种体外和体外模型评估NPI的免疫潜力.
确定归因于三糖的免疫反应是否与NPI有关.

主要方法:

从三糖中提取和描述NPI.
利用了小鼠的毛囊淋巴结 (PLNA) 和脏淋巴细胞模型.
采用了人类外周血液单核细胞细胞因子释放和巨细胞补充激活试验.

主要成果:

在PLNA模型中,NPI导致脚明显胀,IgE和MCP-1增加.
NPIs增强了脏淋巴细胞的增殖和分化.
在人类细胞中,NPIs诱导了细胞因子释放 (例如IL-6,TNF-α) 和补充激活 (C3a/C5a,C4a/Bb).

结论:

特雷荷中的NPI引起了显著的体外免疫反应.
素的免疫性可能归因于NPI,而不是辅助剂本身.
建议对用于高风险生物产品的三糖进行NPI的评估和控制.

关键词:

早期的免疫反应.辅助物质辅助物质辅助物质不纯洁性不纯洁性纳米颗粒纳米颗粒这种树脂含有三糖.

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