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Updated: Jan 21, 2026

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Perspectives on Neuroscience
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我们是否太担心聚酸盐降解? 一个全行业的视角与现实生活中的案例研究
Klaus Wuchner1, Felix Nikels2, Patrick Garidel2
1Johnson&Johnson, DPDS TDS-Biologics, Analytical Development, Hochstr. 201, 8200 Schaffhausen, Switzerland.
Journal of pharmaceutical sciences
|January 19, 2026
概括
在生物治疗中聚酸盐降解是常见的,但可以管理的. 虽然它可以导致颗粒的形成,但关键的质量属性不受影响,如果达到限制,酶性水解是可以接受的.
科学领域:
- 制药科学 制药科学
- 生物技术是生物技术.
- 药物的稳定性 药物的稳定性
背景情况:
- 聚酸盐 (PS) 是生物治疗配方中至关重要的辅助成分.
- 有关长期储存期间的聚酸盐稳定性存在担忧.
- 整个行业的调查强调了临床药物产品中PS含量减少.
研究的目的:
- 评估生物治疗药物产品中的聚酸盐稳定性.
- 调查PS降解对关键质量属性 (CQA) 的影响.
- 了解PS降解机制和粒子形成.
主要方法:
- 对15家生物制药公司进行的全行业调查.
- 对临床开发中的23种生物治疗药物产品 (DPs) 的分析.
- 关于PS降解,安全性和免疫性方面的文献综述.
主要成果:
- 在储存在2-8°C的DP中观察到显著的PS减少.
- 与脂肪酸 (FA) 相关的次可见粒子 (SVP) 在7个DP中形成;可见粒子 (VP) 在1个DP中.
- 降解主要是由于酶性/无特征的机制,而不是氧化.
结论:
- 在实际条件下,聚酸盐降解是可以管理的.
- 如果保持CQAs,可以接受酶化水解.
- 如果FA颗粒形成,建议进行表征和控制策略.
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