Survey and Establishment of Points to Consider for Application of Analytical Techniques to Evaluate Protein Aggregates and Insoluble Particles in Biopharmaceuticals: Experiences in Japan Biopharmaceutical Consortium

Hiroko Shibata, Satoshi Saitoh, Masato Kiyoshi, Yu Hayashi, Kazue Inaba, Shinji Katsura, Maho Sakurai, Yuka Komine, Shinji Okabe, Naomi Ohbayashi, Youko Kita, Hirokazu Kito, Masako Nakano, Kana Miyamoto, Akira Maruyama, Yuya Miyahara, Masanori Noda, Yasuyo Nozawa, Kazutaka Shimbo, Shota Kojima, Shinya Honda, Tetsuo Torisu, Susumu Uchiyama, Akiko Ishii-Watabe

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DOI: 10.1208/s12248-025-01056-3
Published: 2025-04-03
Container: The AAPS Journal
Publisher: Springer Science and Business Media LLC
Open access: unknown

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Cite this work

BibTeX

@article{allodium:10.1208/s12248-025-01056-3,
  title = {Survey and Establishment of Points to Consider for Application of Analytical Techniques to Evaluate Protein Aggregates and Insoluble Particles in Biopharmaceuticals: Experiences in Japan Biopharmaceutical Consortium},
  author = {Hiroko Shibata and Satoshi Saitoh and Masato Kiyoshi and Yu Hayashi and Kazue Inaba and Shinji Katsura and Maho Sakurai and Yuka Komine and Shinji Okabe and Naomi Ohbayashi and Youko Kita and Hirokazu Kito and Masako Nakano and Kana Miyamoto and Akira Maruyama and Yuya Miyahara and Masanori Noda and Yasuyo Nozawa and Kazutaka Shimbo and Shota Kojima and Shinya Honda and Tetsuo Torisu and Susumu Uchiyama and Akiko Ishii-Watabe},
  year = {2025},
  journal = {The AAPS Journal},
  doi = {10.1208/s12248-025-01056-3},
  url = {https://doi.org/10.1208/s12248-025-01056-3}
}

RIS

TY  - JOUR
TI  - Survey and Establishment of Points to Consider for Application of Analytical Techniques to Evaluate Protein Aggregates and Insoluble Particles in Biopharmaceuticals: Experiences in Japan Biopharmaceutical Consortium
AU  - Hiroko Shibata
AU  - Satoshi Saitoh
AU  - Masato Kiyoshi
AU  - Yu Hayashi
AU  - Kazue Inaba
AU  - Shinji Katsura
AU  - Maho Sakurai
AU  - Yuka Komine
AU  - Shinji Okabe
AU  - Naomi Ohbayashi
AU  - Youko Kita
AU  - Hirokazu Kito
AU  - Masako Nakano
AU  - Kana Miyamoto
AU  - Akira Maruyama
AU  - Yuya Miyahara
AU  - Masanori Noda
AU  - Yasuyo Nozawa
AU  - Kazutaka Shimbo
AU  - Shota Kojima
AU  - Shinya Honda
AU  - Tetsuo Torisu
AU  - Susumu Uchiyama
AU  - Akiko Ishii-Watabe
PY  - 2025
JO  - The AAPS Journal
DO  - 10.1208/s12248-025-01056-3
UR  - https://doi.org/10.1208/s12248-025-01056-3
ER  -

APA

Shibata, H., Saitoh, S., Kiyoshi, M., Hayashi, Y., Inaba, K., Katsura, S., Sakurai, M., Komine, Y., Okabe, S., Ohbayashi, N., Kita, Y., Kito, H., Nakano, M., Miyamoto, K., Maruyama, A., Miyahara, Y., Noda, M., Nozawa, Y., Shimbo, K., Kojima, S., Honda, S., Torisu, T., Uchiyama, S., & Ishii-Watabe, A. (2025). Survey and Establishment of Points to Consider for Application of Analytical Techniques to Evaluate Protein Aggregates and Insoluble Particles in Biopharmaceuticals: Experiences in Japan Biopharmaceutical Consortium. The AAPS Journal. https://doi.org/10.1208/s12248-025-01056-3

Source records

crossref · retrieved 2026-09-26T01:06:06.680Z