2022 Fiscal Year Final Research Report
Redesign of the manufacturing process for iPS cell-derived processed products.
| Project/Area Number |
20K12711
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Review Section |
Basic Section 90140:Medical technology assessment-related
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| Research Institution | Osaka University |
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Principal Investigator |
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| Project Period (FY) |
2020-04-01 – 2023-03-31
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| Keywords | 再生医療 / iPS細胞 / 特定細胞加工物 / 製造工程 / QbD / セルソーター / CQA |
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| Outline of Final Research Achievements |
In this study, the concept of risk management was incorporated into the production of cell processed products, the Critical Quality Attributes (CQAs) were set, and process improvements were examined while controlling the values. The CQAs were defined as the efficiency of differentiation induction from iPS cells (%), and the entire process was divided into three major processes, with the cell purification process, including the measurement of CQA values, at the centre, and the improvement of each process was verified while controlling the processes before and after the purification process.
The following improvements were verified: simplification of the number of steps by using the closed system for differentiation induction culture, labelled-free cell sorting for cell purification, and final product preparation by controlling the culture period and cell density for sheet production, respectively.
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| Free Research Field |
再生医療
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| Academic Significance and Societal Importance of the Research Achievements |
リスクマネージメントに基づく工程管理については、CQA値を軸として管理するスタイルが細胞加工物に対しても実際に適用可能であると示すことが出来た。
工程の改良内容については、開始当初は蛍光標識の組合せ変更など既存手法での対応を想定していたが、検討の過程で無標識セルソーターや閉鎖系培養システムなど新規技術を取り入れることにつながった。これらの改良手法は、無標識セルソーターであれば生物由来原料不使用による感染持込および残留に起因するリスク解消、閉鎖系培養システムであれば製造作業負担の低減のみならず製造施設簡易化による大幅なコスト削減など、再生医療実用化に付随した課題解決策を提示することが出来た。
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