提高了多属性方法的质量准确性和精度,使用新的内部校准的高分辨率轨道轨道式质量探测器
Andrew W Dawdy1, Edna A Trujillo1, Zhenjiu Liu1
1BioTherapeutics Pharmaceutical Sciences, Pfizer Inc., Chesterfield, Missouri 63017, United States.
Analytical chemistry
|April 16, 2024
概括
一个新的质量探测器可以使用多属性方法 (MAM) 进行生物治疗质量属性的稳健监测. 这种低维护的系统提供了高质量准确度和精度,可靠的生物制药开发和质量控制.
科学领域:
- 生物制药开发 生物制药开发
- 分析化学 分析化学
- 质谱测量质量谱测量
背景情况:
- 确保生物治疗的安全性和有效性需要了解产品质量属性 (PQA) 以及它们对稳定性的影响.
- 多属性方法 (MAM) 使用LC-MS映射,通过监测PQAs来支持生物治疗开发.
研究的目的:
- 为了评估低维护,MAM-ready质量探测器用于监测蛋白质分解性消化蛋白中的PQAs.
- 为了评估仪器的质量准确度,精度,灵敏度和MAM应用的长期稳定性.
主要方法:
- 对一个MAM-ready质量探测器的评估,该探测器具有针对相对量化的优化源参数.
- 使用内置的一点质量校准和在飞行中的质量校正用于高分辨率质量谱.
- 在54天的时间内进行评估的监测,质量准确度低于1ppm,质量公差<3ppm.
主要成果:
- 评估的质量探测器表现出高灵敏度,最小的来源碎片化,以及强大的PQAs的相对量化.
- 在长时间 (54天) 进行质监测时,达到1ppm以下的质量准确度和<3ppm的质量容忍度.
- 来自仪器的LC-MS MAM数据与以前的MAM系统和传统测定有很强的一致性.
结论:
- 评估的MAM-ready质量探测器适用于生物制药开发中可靠的PQA监测.
- 它的高精度,精度和稳定性支持质量控制的强大和特定的监测.
- 该仪器提供了一种低维护,高性能解决方案,用于推进生物治疗特征.
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