Collaborative Study for Analysis of Subvisible Particles Using Flow Imaging and Light Obscuration: Experiences in Japanese Biopharmaceutical Consortium

• Published in: Journal of pharmaceutical sciences Vol. 108; no. 2; pp. 832 - 841
• Main Authors: Kiyoshi, Masato, Shibata, Hiroko, Harazono, Akira, Torisu, Tetsuo, Maruno, Takahiro, Akimaru, Michiko, Asano, Yuuka, Hirokawa, Mai, Ikemoto, Keisuke, Itakura, Yukari, Iwura, Takafumi, Kikitsu, Aya, Kumagai, Takashi, Mori, Naoki, Murase, Hiroaki, Nishimura, Hirotaka, Oda, Atsushi, Ogawa, Taiichiro, Ojima, Takuma, Okabe, Shinji, Saito, Shuntaro, Saitoh, Satoshi, Suetomo, Hiroyuki, Takegami, Kazuhiro, Takeuchi, Momoko, Yasukawa, Hidehito, Uchiyama, Susumu, Ishii-Watabe, Akiko
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.02.2019
• Subjects: image analysis; Immunoglobulins, Intravenous - chemistry; Japan; Light; microparticle(s); Optical Imaging; Particle Size; Protein Aggregates; protein aggregation; Technology, Pharmaceutical; Japan; standards; particle size; microparticle(s); image analysis; protein aggregation

The evaluation of subvisible particles, including protein aggregates, in therapeutic protein products has been of great interest for both pharmaceutical manufacturers and regulatory agencies. To date, the flow imaging (FI) method has emerged as a powerful tool instead of light obscuration (LO) due t...