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

[11p-M116-4] Three-Dimensional Reflectivity Detection Method for Screening of Protein Aggregation of Biopharmaceuticals

〇Yumiko Anzai¹, Kentaro Osawa¹, Hiroyuki Minemura¹, Mariko Umeda¹, Manabu Shiozawa¹ (1.Hitachi, Ltd. R&D)

Keywords:Optical measurement method, protein aggregates

While biopharmaceuticals such as antibody drugs have high therapeutic effect on intractable diseases, toxicity (immunogenicity) due to protein aggregation has been reported. Although concentration control by light blocking method etc. has been done so far, measurement technology of submicron size aggregates has not been sufficiently established. We are developing a three-dimensional reflectivity detection method corresponding to prediction of submicron region regulation. Submicron sized poly-beads standard particles and silica-beads standard particles having the same refractive index (1.43) as the protein aggregate were measured. As a result, the size separation in the size mixed system of the poly-beads and the linearity between the detection number and the concentration in the silica-beads of φ 0.3 μm were confirmed.