2022 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), 特任助教 (20842206)
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| Project Period (FY) |
2022-04-01 – 2025-03-31
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| Keywords | freeze-drying / process optimization / mechanistic modelling / Biopharmaceuticals / cake collapse |
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| Outline of Annual Research Achievements |
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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| 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 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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| Strategy for Future Research Activity |
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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