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寻求下调比例代表性:如何利用CFD来设计疫苗剪切研究

Andrea Albano¹, Silvio Colomba¹, Angelo Palmese¹

¹Global Drug Product Development, Technical R&D-R&D, GSK, Siena, Italy.

Pharmaceutical development and technology

|March 18, 2024

概括

计算流体动力学 (CFD) 评估了用于疫苗药物制品 (DP) 配方的缩放式系统 (SDS) 设计. 旋转剪切缩放为工艺特征提供了一个比尖端速度等价的更具代表性的SDS.

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.
疫苗开发疫苗开发

背景情况:

设计具有代表性的缩放系统 (SDS) 对疫苗药物产品 (DP) 过程表征至关重要.
式反应堆 (STR) 常用于DP配方,需要仔细缩小规模以模仿制造条件.
了解SDS中的剪切历史对于保持DP质量属性至关重要.

研究的目的:

为了评估计算流体动力学 (CFD) 设计一个代表性的SDS的辅助疫苗DP.
为了比较两个调动速度下降的策略:尖端速度等价和旋转剪切.
为了确定最佳的缩放方法,以准确地反映制造规模的剪切条件.

主要方法:

利用CFD模拟来分析STR中的工艺工程师参数 (PEP).
使用"通道数"概念来研究SDS中的剪切历史.
研究了倾斜速度等价性和旋转剪切作为SDS设计的缩放标准.

主要成果:

差价合约模拟表明,倾斜速度等效会在剪切方面创建最坏的SDS.
旋转剪切缩放方法显示了设计更具代表性的SDS的潜力.
监测"体外相对强度"强调了扩展策略对DP关键质量属性的影响.

结论:

选择缩小规模的方法显著影响SDS对工艺表征的代表性.
旋转切割为SDS设计在疫苗制造中的传统尖端速度等价提供了一个有希望的替代方案.
使用适当的缩放标准准确的SDS设计对于可靠的过程开发和验证至关重要.

关键词:

计算流体动力学的流体动力学.在QbD中,它是QbD.辅助剂是一种辅助剂.发展过程发展过程.缩小规模的系统系统.的水箱起来了

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