药物瓶中的冷过程通过冰芯采样进行表征
Sarah S Peláez1,2, Hanns-Christian Mahler1,2,3, Pau Rubirola Vila1
1ten23 health AG, Mattenstrasse 22, 4058, Basel, Switzerland.
AAPS PharmSciTech
|May 7, 2024
概括
在生物药物物质 (DS) 结过程中最大限度地降低冷度是蛋白质稳定的关键. 一种新的冰芯采样方法有效地测量了冷DS瓶中的冷度,有助于过程优化.
科学领域:
- 生物制药制造业 生物制药制造业
- 工艺工程是过程工程.
- 蛋白质的稳定性 蛋白质的稳定性
背景情况:
- 生物药物物质 (DS) 的冷至关重要,但由于冷度,可以导致蛋白质聚合和颗粒形成.
- 宏观冷度受结速率,容器类型,尺寸,填充水位和设备的影响.
- 目前评估冷度的方法受到产品要求和破坏性采样的限制.
研究的目的:
- 开发一种简单,可扩展的方法来实验性地表征冷度在冷的DS瓶中.
- 为了确定一个可靠的指标来测量冷度.
- 为了证明该方法在比较不同的冷协议时的实用性.
主要方法:
- 开发一种新的冰芯采样技术,用于使用替代溶液的冷DS瓶.
- 通过奥斯molality,histidine 和 polysorbate 80 (PS80) 度来测量冷度.
- 在不同结温度 (-80°C vs -40°C) 的瓶中冷度的比较.
主要成果:
- 在冷的DS瓶中部的轴心冰芯被确定为冷度的标志.
- 度被证明是定量化度的敏感和可靠的读数.
- 长时间的冷应力时间与轴心中心的冷度增加相关,通过度测量.
结论:
- 开发的冰芯采样方法提供了一种简单而有效的方法,可以在规模上对冷DS瓶中的冷度进行表征.
- 度是评估冷度及其对冷过程中蛋白质稳定性的影响的合适指标.
- 这种方法有助于理解和优化冷过程,以最大限度地降低冷度并保持药物质量.
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