对一个新的峰值检测函数进行比较,用于选择相应的多属性方法系统
Eriko Numao1, Kumi Yanagisawa1, Yuki Yagi1
1Bio Process Research and Development Laboratories, Manufacturing Division, Kyowa Kirin Co., Ltd., Takasaki, Gunma 370-0013, Japan.
Journal of bioscience and bioengineering
|November 10, 2024
概括
多属性方法 (MAM) 允许用于生物治疗质量控制的新峰值检测 (NPD). 这项研究证实了在不同系统中优化NPD参数的实用方法,突出了软件和仪器功能.
科学领域:
- 生物制药学分析分析
- 分析化学是一种分析化学.
- 质量控制 质量控制
背景情况:
- 多属性方法 (MAM) 对于生物治疗质量控制至关重要.
- 在MAM中新峰值检测 (NPD) 识别出意想不到的样本变化,支持其采用传统方法.
- 对于释放,稳定性,可比性和研究阶段产品属性识别来说,NPD非常有价值.
研究的目的:
- 验证一个原始的决策方法,以优化NPD处理参数.
- 评估这种方法在两个不同的分析系统中的适用性.
- 为了比较不同系统之间的NPD功能的性能.
主要方法:
- 在两个不同的系统上优化NPD处理参数.
- 评估参数优化基于检测关键差异而没有错误阳性.
- 对NPD的比较分析结果显示了系统之间的可重复性.
主要成果:
- 该研究证实了开发的NPD参数优化方法的适用性.
- 在两个测试系统之间,NPD结果的可复制性有所不同.
- 发现NPD能力取决于仪表分辨率和软件功能.
结论:
- 拟议的NPD参数优化策略对于治疗性蛋白质开发是实用的.
- 对于NPD的系统选择应考虑仪器和软件功能,以获得最佳性能.
- 这项研究首次对不同系统的NPD结果进行了比较,有助于选择适合目的的系统.
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