A Collaborative Study on the Classification of Silicone Oil Droplets and Protein Particles Using Flow Imaging Method.

Autor:	Shibata H; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan. Electronic address: h-shibata@nihs.go.jp., Terabe M; Pharmaceutical Technology Division, Analytical Development Department, Chugai Pharmaceutical Co. Ltd., 5-1 Ukima, 5-chome, Kita-ku, Tokyo 115-8543 Japan., Shibano Y; Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan., Saitoh S; Pharmaceutical Technology Division, Analytical Development Department, Chugai Pharmaceutical Co. Ltd., 5-1 Ukima, 5-chome, Kita-ku, Tokyo 115-8543 Japan., Takasugi T; Analytical Research Laboratories, Pharmaceutical Technology, Astellas Pharma. Inc., 5-2-3 Tokodai, Tsukuba, Ibaraki, 300-2698, Japan., Hayashi Y; Analytical Research Laboratories, Pharmaceutical Technology, Astellas Pharma. Inc., 5-2-3 Tokodai, Tsukuba, Ibaraki, 300-2698, Japan., Okabe S; Research Division, CMC Development Research, Formulation Research Unit, Formulation Development, JCR Pharmaceuticals Co., Ltd., 2-2-9 Murotani, Nishi-ku, Kobe, Hyogo 651-2241, Japan., Yamaguchi Y; Research Division, CMC Development Research, Formulation Research Unit, Formulation Development, JCR Pharmaceuticals Co., Ltd., 2-2-9 Murotani, Nishi-ku, Kobe, Hyogo 651-2241, Japan., Yasukawa H; Research Division, CMC Development Research, Formulation Research Unit, Formulation Development, JCR Pharmaceuticals Co., Ltd., 2-2-9 Murotani, Nishi-ku, Kobe, Hyogo 651-2241, Japan., Suetomo H; Bio Process Research and Development Laboratories, Production Division, Kyowa Kirin Co., Ltd., 100-1, Hagiwara-machi, Takasaki, Gunma 370-0013, Japan., Miyanabe K; CMC Regulatory and Analytical R&D., Ono Pharmaceutical Co., Ltd., 1-1, Sakurai 3-chome, Shimamoto-cho, Mishima-gun, Osaka, 618-8585, Japan., Ohbayashi N; Pharmaceutical Research Center, Formulation Research Lab., Meiji Seika Pharma Co., Ltd., 788 Kayama, Odawara, Kanagawa, 250-0852, Japan., Akimaru M; Analytical & Quality Evaluation Research Laboratories, Daiichi Sankyo Co., Ltd., 1-12-1, Shinomiya, Hiratsuka, Kanagawa, 254-0014, Japan., Saito S; Analytical & Quality Evaluation Research Laboratories, Daiichi Sankyo Co., Ltd., 1-12-1, Shinomiya, Hiratsuka, Kanagawa, 254-0014, Japan., Ito D; Japan Blood Products Organization, 1007-31 Izumisawa, Chitose, Hokkaido, 066-8610, Japan., Nakano A; Japan Blood Products Organization, 1007-31 Izumisawa, Chitose, Hokkaido, 066-8610, Japan., Kojima S; Pharmaceutical Laboratory, Mochida Pharmaceutical Co., Ltd. 342 Gensuke, Fujieda, Shizuoka, 426-8640, Japan., Miyahara Y; CMC Modality Technology Laboratories, Production Technology & Supply Chain Management Division, Mitsubishi Tanabe Pharma Corporation, 7473-2, Onoda, Sanyoonoda-shi, Yamaguchi, 756-0054 Japan., Sasaki K; CMC Modality Technology Laboratories, Production Technology & Supply Chain Management Division, Mitsubishi Tanabe Pharma Corporation, 7473-2, Onoda, Sanyoonoda-shi, Yamaguchi, 756-0054 Japan., Maruno T; U-Medico Inc., 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan., Noda M; U-Medico Inc., 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan., Kiyoshi M; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan., Harazono A; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan., Torisu T; Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan., Uchiyama S; Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan., Ishii-Watabe A; Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan.
Jazyk:	angličtina
Zdroj:	Journal of pharmaceutical sciences [J Pharm Sci] 2022 Oct; Vol. 111 (10), pp. 2745-2757. Date of Electronic Publication: 2022 Jul 14.
DOI:	10.1016/j.xphs.2022.07.006
Abstrakt:	In this study, we conducted a collaborative study on the classification between silicone oil droplets and protein particles detected using the flow imaging (FI) method toward proposing a standardized classifier/model. We compared four approaches, including a classification filter composed of particle characteristic parameters, principal component analysis, decision tree, and convolutional neural network in the performance of the developed classifier/model. Finally, the points to be considered were summarized for measurement using the FI method, and for establishing the classifier/model using machine learning to differentiate silicone oil droplets and protein particles. Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
Databáze:	MEDLINE
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