[11p-M116-1~15] 1.5 Instrumentation, measurement and Metrology

[11p-M116-5] Electron Microscopy for Protein Aggregates of Biopharmaceuticals

〇Kumi Motai¹, Ohshima Takashi¹ (1.Hitachi, Ltd. R&D)

Keywords:scanning electron microscope, protein aggregates

In recent years, in the field of biopharmaceuticals, the inspection of protein aggregates in drugs is necessary because the aggregates create the risk of immunogenicity. However, there is no established technique to measure sub-micron sized aggregates. As a solution of this problem, the method of cohesion molecule measurement using a scanning electron microscope (SEM) has been investigated. It was confirmed that the suction filtration system for sampling molecules using membrane with micro-size pore and low-acceleration backscattered electron (BSE) observation in low-vacuum SEMs are optimum for protein aggregates imaging. The enormous volume image data was taken by automatic measurement and the machine learning technology was used to shorten time for molecule analysis in BSE images. This method has achieved the measurement of density and size distribution of sub-micron sized protein aggregates in antibody reagent sample.