2023 Fiscal Year Research-status Report
Multiscale hybrid modeling for design and operation of freeze-drying processes in biopharmaceutical manufacturing
| Project/Area Number |
22K14535
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| Research Institution | The University of Tokyo |
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Principal Investigator |
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), 准教授 (20842206)
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| Project Period (FY) |
2022-04-01 – 2025-03-31
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| Keywords | Freeze drying / Process optimization / Biopharmaceuticals / Modelling / Process design / Hybrid modelling |
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| Outline of Annual Research Achievements |
Freeze drying is essential to allow the storage and distribution of unstable biopharmaceuticals, e.g., therapeutic proteins. However, the process is time-and resource-intensive. This research aims to provide design and operation improvements to save production time without affecting product quality. Collaborations with industrial partners were established. The collected data from was used to develop process models for different operations, e.g., drying. The drying process is one of the most time-consuming steps and vulnerable to issues affecting the product quality. An index was developed relating product quality issues with changes in physical properties for standard materials used as additives.
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| Current Status of Research Progress |
Current Status of Research Progress
2: Research has progressed on the whole more than it was originally planned.
Reason
The work is progressing according to plan. Vial scale models have been developed for the drying process. An index for product quality has been developed. Collaborations with industrial partners are proceeding smoothly.
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| Strategy for Future Research Activity |
In the future, the model will be integrated with the quality index to optimize the freeze-drying operation and provide a guide based on material properties and process conditions. Process optimization using the developed integrated model will take place.
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| Causes of Carryover |
Due to difficulties travelling this fiscal year, I couldn’t participate in the planned conferences to present the work. The remaining amount will be spent on conference participation and travel fees in the next fiscal year as well as honoraria for performing modelling work.
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