In-situ evaluation of frozen protein solutions to maintain the stability of biopharmaceuticals

2015 Fiscal Year Final Research Report

• Project/Area Number: 26630066
• Research Category: Grant-in-Aid for Challenging Exploratory Research
• Allocation Type: Multi-year Fund
• Research Field: Thermal engineering
• Research Institution: Kyushu University
• Principal Investigator: TAKAMATSU Hiroshi 九州大学, 工学(系)研究科(研究院), 教授 (20179550)
• Co-Investigator(Kenkyū-buntansha): KURATA Kosaku 九州大学, 大学院工学研究院, 准教授 (00368870) ; FUKUNAGA Takanobu 九州大学, 大学院工学研究院, 技術職員 (60591196)
• Project Period (FY): 2014-04-01 – 2016-03-31
• Keywords: 凍結保存 / バイオ医薬品 / ラマンイメージング / タンパク質変性

Outline of Final Research Achievements

Freezing of protein solutions is an important process for production, transportation, and storage of biopharmaceuticals. The aim of this study was to minimize the denaturation of an organic matter due to the freezing process. A lysozyme aqueous solution was used as a model protein with trehalose as a cryoprotective agent. The binary solution or each component solution was frozen in a microchannel on a directional solidification stage combined with a laser Raman microscope, and observed to obtain spatial distribution of water, ice, and each solute. Protein denaturation was also evaluated from the Raman spectra. These experimental results revealed that optimization of lysozyme/trehalose concentration and the freezing speed led to colocalization of both solutes, which is helpful in enhancing the stability of lysozyme because of the cryoprotective effect of trehalose.

Free Research Field

熱工学