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

Research Project

Project/Area Number 22K14535
Research Category

Grant-in-Aid for Early-Career Scientists

Allocation TypeMulti-year Fund
Review Section Basic Section 27020:Chemical reaction and process system engineering-related
Research InstitutionThe University of Tokyo

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)

Project Period (FY) 2022-04-01 – 2025-03-31
Project Status Granted (Fiscal Year 2023)
Budget Amount *help
¥4,550,000 (Direct Cost: ¥3,500,000、Indirect Cost: ¥1,050,000)
Fiscal Year 2024: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
Fiscal Year 2023: ¥1,950,000 (Direct Cost: ¥1,500,000、Indirect Cost: ¥450,000)
Fiscal Year 2022: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
KeywordsFreeze drying / Process optimization / Biopharmaceuticals / Modelling / Process design / Hybrid modelling / freeze-drying / process optimization / mechanistic modelling / cake collapse
Outline of Research at the Start

This work develops multiscale hybrid models to rationalize the design and operation of freeze-drying processes. The models can be used for process optimization, failure detection to improve supply robustness of biopharmaceuticals, and further to increase the flexibility of drug distribution.

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.

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.

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.

Report

(2 results)
  • 2023 Research-status Report
  • 2022 Research-status Report
  • Research Products

    (2 results)

All 2024 2023

All Journal Article (1 results) (of which Int'l Joint Research: 1 results,  Peer Reviewed: 1 results,  Open Access: 1 results) Presentation (1 results) (of which Int'l Joint Research: 1 results,  Invited: 1 results)

  • [Journal Article] Roles of mechanistic, data-driven, and hybrid modeling approaches for pharmaceutical process design and operation2024

    • Author(s)
      Mohamed Rami Gaddem, Junu Kim, Kensaku matsunami, Yusuke Hayashi, Sara Badr, Hirokazu Sugiyama
    • Journal Title

      Current Opinion in Chemical Engineering

      Volume: 44 Pages: 101019-101019

    • DOI

      10.1016/j.coche.2024.101019

    • Related Report
      2023 Research-status Report
    • Peer Reviewed / Open Access / Int'l Joint Research
  • [Presentation] The role of data-driven and hybrid modelling in biopharmaceutical manufacturing2023

    • Author(s)
      Sara Badr
    • Organizer
      SCEJ 89th Annual Meeting/ International Chemical Engineering symposia (IChES) 2023
    • Related Report
      2022 Research-status Report
    • Int'l Joint Research / Invited

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Published: 2022-04-19   Modified: 2024-12-25  

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