2019 Fiscal Year Final Research Report
Physico-chemical and mathematical analyses of immune related signal induced by antibody aggregates
| Project/Area Number |
17H03975
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| Research Category |
Grant-in-Aid for Scientific Research (B)
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| Allocation Type | Single-year Grants |
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| Section | 一般 |
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| Research Field |
Physical pharmacy
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| Research Institution | Osaka University |
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Principal Investigator |
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| Co-Investigator(Kenkyū-buntansha) |
保仙 直毅 大阪大学, 医学系研究科, 教授 (10456923)
大戸 梅治 東京大学, 大学院薬学系研究科(薬学部), 准教授 (90451856)
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| Project Period (FY) |
2017-04-01 – 2020-03-31
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| Keywords | バイオ医薬 / 抗体医薬 / 安定性 / 凝集 / タンパク質 / 界面 |
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| Outline of Final Research Achievements |
Based on this research, quantitative assessment of protein aggregates in biopharmaceuticals are established, and factors influencing protein aggregation as well as relation of immunological impact of protein aggregates were clarified. Specifically impact of protein-silicone oil drop released from syringe barrel protein complex on immune system is significant thus design of container is important. This study also indicate that interface stability of proteins are of importance to suppress protein aggregation, besides colloidal and conformational stabilities that have been pointed out as important factors for protein stability in solution. Based on this study,minimizing physical stress like vibration and impact should be a clue to stabilize therapeutic proteins in solution.
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| Free Research Field |
生物物理化学
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| Academic Significance and Societal Importance of the Research Achievements |
本研究は、近年、利用されているバイオ医薬品の安定性と安全性に関するものであるが、これまで不明点が多かったタンパク質凝集体と副作用の関係を実験的に示唆することができた社会的意義の大きい研究成果である。特に、製薬企業から医療現場で利用される実際の場面へとフィードバックが可能な知見が数多く含まれており、かつ、応急処置的な対応では無く、包括的かつ根本的に医薬品の安定性を高めることが可能となることから、科学的意義は当然ながら、産業的意義が大きいといえる。
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