一种实验和计算方法,用于开发混合液体的混合工艺在不混的坦克
Mehrrad Saadatmand1, Mehak Mehta2, Kelly Walsh3
1Biologics & Advanced Therapy Medicinal Products, Biogen Inc., Cambridge, MA, USA. mehrrad.saadatmand@biogen.com.
Pharmaceutical research
|August 11, 2023
概括
生物制药混合研究现在可以使用具有成本效益的替代解决方案和计算流体动力学 (CFD) 模拟. 这些方法准确地预测混合参数,减少了与药物物质的昂贵规模实验.
科学领域:
- 生物制药制造业 生物制药制造业
- 化学工程是化学工程的重要组成部分.
- 流体动力学 流体动力学
背景情况:
- 液体混合是生物制药药品制造中的关键单元操作,涉及药物物质 (DS) 的稀释或聚合.
- 传统的规模混合研究使用有价值的DS,导致高成本和几何缩放的挑战.
- 现有的盐痕量模型缺乏对准确的大规模研究预测的代表性.
研究的目的:
- 开发具有成本效益的方法,用于预测生物制药制造中的混合参数.
- 为了将计算流体动力学 (CFD) 模拟与混合研究的大规模实验进行比较.
- 为了验证使用替代溶液代替药物质的使用,进行大规模混合评估.
主要方法:
- 进行了大规模的混合实验,使用具有替代溶液的全尺寸.
- 采用并比较各种计算流体动力学 (CFD) 模拟技术.
- 对实验结果进行验证的CFD预测,以确定可靠的计算方法.
主要成果:
- 替代解决方案在大规模研究中可靠地确定混合参数,取代了昂贵的药物产品.
- 使用大模拟 (LES) 粘性模型和滑动网的短暂CFD模拟准确预测了混合参数.
- 该研究确定了可靠的CFD技术,用于预测生物制药过程中的混合行为.
结论:
- 建立了一种实用和可靠的方法,用于混合不同动力粘度的可混合液体的混合研究.
- 开发的方法显著降低了生物制药行业的常规混合研究成本.
- 提高效率和结果的准确性使混合操作的积极扩展成为可能.
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