| 研究課題/領域番号 |
22K14535
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| 研究機関 | 東京大学 |
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研究代表者 |
バドラ サラ・サミール・レヤド 東京大学, 大学院工学系研究科(工学部), 特任助教 (20842206)
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| 研究期間 (年度) |
2022-04-01 – 2025-03-31
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| キーワード | freeze-drying / process optimization / mechanistic modelling / Biopharmaceuticals / cake collapse |
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| 研究実績の概要 |
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.
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| 現在までの達成度 (区分) |
現在までの達成度 (区分)
2: おおむね順調に進展している
理由
The work is progressing according to plan. Vial scale models have been developed and collaborations have been established with industrial and academic partners to continue the model validation and development for different scales and materials.
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| 今後の研究の推進方策 |
In the future, the model will be developed further to include further sub-processes, e.g., freezing. The impact of material properties and process conditions on product quality will be investigated and modelled. The model will be validated for different materials and process conditions. Optimization of the whole process operation through the developed integrated process model will take place.
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