药品释放分析仪器变化的通用研究设计
Anne B Ries1, Maximilian N Merkel1, Kristina Coßmann1
1Quality Control, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany.
Electrophoresis
|June 26, 2025
概括
药品质量控制需要一致的分析方法. 一项新的仪器可比性研究确保了仪器之间的无过渡,防止了昂贵的重新验证,并保持了发布分析的数据完整性.
科学领域:
- 制药科学 制药科学
- 分析化学 分析化学
- 生物技术是生物技术.
背景情况:
- 数十年来保持一致的分析方法性能对于制药质量控制 (QC) 至关重要.
- 仪器硬件/软件更新或供应商变更挑战了药品质量控制中的长期分析方法可靠性.
- 确保分析工具之间的可比性对于不间断的产品发布分析至关重要.
研究的目的:
- 设计和实施一项有效的仪器可比性研究,用于制药品质检.
- 评估分析仪器之间的潜在性能差异.
- 为风险评估和关于仪器转换或更新的决策提供数据驱动的基础.
主要方法:
- 一个普遍适用的研究设计,包括在新仪器上进行两项实验.
- 生成具有统计意义的数据集,与历史数据或验证数据进行比较.
- 在良好的制造实践 (GMP) 环境中使用成像毛细管异电聚焦 (icIEF) 仪器 (ICE3 vs. Maurice C) 的实施.
主要成果:
- 该研究证实莫里斯C仪器与ICE3相比具有同等或更高的性能.
- 所有测试的参数都在Maurice C.上显示了可比或更好的结果.
- 生成的数据支持在莫里斯C.上继续进行释放icIEF测量.
结论:
- 开发的仪器可比性研究设计是高效的,广泛适用于释放分析方法.
- 该研究提供了一种以科学为基础的方法来管理仪器变化,可能避免完全重新验证.
- 通过数据支持的仪器可比性评估,可以实现关键释放分析的无延续.
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