优化研究药物瓶中的冷/解过程的方法
Sarah S Peláez1,2, Hanns-Christian Mahler1,3, Jörg Huwyler3
1ten23 Health AG, Mattenstrasse 22, 4058 Basel, Switzerland.
Methods and protocols
|September 23, 2024
概括
优化生物药物物质 (DS) 的冷和解 (F/T) 过程需要了解产品独立的参数. 本研究详细介绍了温度分析和液体采样方法,以控制冷度,并在大规模制造过程中确保产品质量.
科学领域:
- 生物制药制造业 生物制药制造业
- 工艺工程的过程工程.
- 药物物质的稳定性 药物物质的稳定性
背景情况:
- 生物药物物质 (DS) 的冷增强了稳定性和制造灵活性.
- 制造规模的冷和解 (F/T) 可能会由于冷度而影响DS质量.
- 产品独立的过程参数显著影响F/T结果.
研究的目的:
- 优化在散装DS瓶中研究产品独立的工艺参数的方法.
- 建立可靠的方法来监测F/T期间的温度概况和度梯度.
- 为制造规模实施这些测量技术提供技术细节.
主要方法:
- 在DS冷和解过程中开发和优化温度档案记录.
- 实施解后的液体采样,以量化度梯度.
- 使用摄像头辅助检查来识别最后的结点和解点以及实际解时间.
主要成果:
- 实验证明温度记录的测量位置,包括最后一个结点.
- 成功实施摄像头辅助检查,以确保融化动态.
- 优化测量设置的详细技术描述.
结论:
- 优化的方法允许更好地理解和控制DS的F / T流程.
- 设备的表征和适当的测量点的选择对于资源意识研究至关重要.
- 这些方法有助于在大规模制造过程中确保DS质量和工艺稳定性.
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