Multiscale hybrid modeling for design and operation of freeze-drying processes in biopharmaceutical manufacturing

用于生物制药制造中冷冻干燥工艺设计和操作的多尺度混合建模

基本信息

项目摘要

Freeze drying of unstable biopharmaceuticals is an important process for ensuring the availability of important drug products such as therapeutic proteins like monoclonal antibodies. Process design has traditionally been based on an empirical basis and therefore using conservative process conditions. Models correlating quality-related attributes to process conditions had been largely missing.During this year, preliminary vial-scale models for the drying step were established to predict drying time. The impact of varying process conditions on process performance and product quality, e.g., the cake collapse phenomenon, was investigated for standard materials used as additives during the freeze-drying process. The uncertainty in determining process parameters was studied. Building an integrated model to include product quality is ongoing. The intended model developments include the application to different types of materials used as additives during freeze-drying. This can lead to the safe development of aggressive drying processes, which can offer significant time and cost savings. This method can serve as a systematic basis for the combined process and material development/optimization by industry and academia.Collaborations were established with various experimental and industrial groups for further model development and validation.
不稳定生物药物的冷冻干燥是确保重要药物产品(如单克隆抗体等治疗性蛋白质)可用性的重要工艺。工艺设计传统上是基于经验的,因此使用保守的工艺条件。将质量相关属性与工艺条件相关联的模型在很大程度上缺失。在这一年中,初步建立了干燥步骤的小瓶规模模型,以预测干燥时间。不同工艺条件对工艺性能和产品质量的影响,例如,研究了在冷冻干燥过程中用作添加剂的标准物质的滤饼塌陷现象。对工艺参数测定的不确定度进行了研究。正在建立一个包含产品质量的集成模型。预期的模型开发包括应用于冷冻干燥过程中用作添加剂的不同类型的材料。这可以安全地开发侵蚀性干燥工艺,从而节省大量时间和成本。该方法可作为工业界和学术界联合开发/优化工艺和材料的系统基础。与各种实验和工业团体建立了合作关系,以进一步开发和验证模型。

项目成果

期刊论文数量(1)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
The role of data-driven and hybrid modelling in biopharmaceutical manufacturing
数据驱动和混合建模在生物制药制造中的作用
  • DOI:
  • 发表时间:
    2023
  • 期刊:
  • 影响因子:
    0
  • 作者:
    Shuji Ohsaki;Akito Teranishi;Hideya Nakamura;Satoru Watano;Sara Badr
  • 通讯作者:
    Sara Badr
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