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

Flow imaging Machine learning Protein particles Silicone oil

Journal

Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R

Informations de publication

Date de publication:
10 2022
Historique:
received: 01 03 2022
revised: 07 07 2022
accepted: 07 07 2022
pubmed: 16 7 2022
medline: 21 9 2022
entrez: 15 7 2022
Statut: ppublish

Résumé

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.

Identifiants

pubmed: 35839866
pii: S0022-3549(22)00298-2
doi: 10.1016/j.xphs.2022.07.006
pii:
doi:

Substances chimiques

Proteins 0
Silicone Oils 0
Silicones 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

2745-2757

Informations de copyright

Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

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.

Auteurs

Hiroko 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.

Masahiro Terabe (M)

Pharmaceutical Technology Division, Analytical Development Department, Chugai Pharmaceutical Co. Ltd., 5-1 Ukima, 5-chome, Kita-ku, Tokyo 115-8543 Japan.

Yuriko Shibano (Y)

Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan.

Satoshi Saitoh (S)

Pharmaceutical Technology Division, Analytical Development Department, Chugai Pharmaceutical Co. Ltd., 5-1 Ukima, 5-chome, Kita-ku, Tokyo 115-8543 Japan.

Tomohiro Takasugi (T)

Analytical Research Laboratories, Pharmaceutical Technology, Astellas Pharma. Inc., 5-2-3 Tokodai, Tsukuba, Ibaraki, 300-2698, Japan.

Yu Hayashi (Y)

Analytical Research Laboratories, Pharmaceutical Technology, Astellas Pharma. Inc., 5-2-3 Tokodai, Tsukuba, Ibaraki, 300-2698, Japan.

Shinji 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.

Yuka 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.

Hidehito 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.

Hiroyuki Suetomo (H)

Bio Process Research and Development Laboratories, Production Division, Kyowa Kirin Co., Ltd., 100-1, Hagiwara-machi, Takasaki, Gunma 370-0013, Japan.

Kazuhiro 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.

Naomi Ohbayashi (N)

Pharmaceutical Research Center, Formulation Research Lab., Meiji Seika Pharma Co., Ltd., 788 Kayama, Odawara, Kanagawa, 250-0852, Japan.

Michiko Akimaru (M)

Analytical & Quality Evaluation Research Laboratories, Daiichi Sankyo Co., Ltd., 1-12-1, Shinomiya, Hiratsuka, Kanagawa, 254-0014, Japan.

Shuntaro Saito (S)

Analytical & Quality Evaluation Research Laboratories, Daiichi Sankyo Co., Ltd., 1-12-1, Shinomiya, Hiratsuka, Kanagawa, 254-0014, Japan.

Daisuke Ito (D)

Japan Blood Products Organization, 1007-31 Izumisawa, Chitose, Hokkaido, 066-8610, Japan.

Atsushi Nakano (A)

Japan Blood Products Organization, 1007-31 Izumisawa, Chitose, Hokkaido, 066-8610, Japan.

Shota Kojima (S)

Pharmaceutical Laboratory, Mochida Pharmaceutical Co., Ltd. 342 Gensuke, Fujieda, Shizuoka, 426-8640, Japan.

Yuya 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.

Kenji 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.

Takahiro Maruno (T)

U-Medico Inc., 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.

Masanori Noda (M)

U-Medico Inc., 2-1 Yamadaoka, Suita, Osaka, 565-0871, Japan.

Masato Kiyoshi (M)

Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan.

Akira Harazono (A)

Division of Biological Chemistry and Biologicals, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki, Kanagawa 210-9501, Japan.

Tetsuo Torisu (T)

Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan.

Susumu Uchiyama (S)

Department of Biotechnology, Graduate School of Engineering, Osaka University, 2-1 Yamadaoka, Suita, Osaka 565-0871, Japan.

Akiko 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.

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