Shibata Hiroko 柴田寛子

Researcher Number	60462769
Affiliation (Current)	2025: 国立医薬品食品衛生研究所, 生物薬品部, 室長
Affiliation (based on the past Project Information) *help	2017 – 2019: 国立医薬品食品衛生研究所, 生物薬品部, 室長
Review Section/Research Field	Principal Investigator Medical pharmacy
Keywords	Principal Investigator 補体活性化 / 凝集体 / 補体 / バイオ医薬品

Relationship between physicochemical properties of protein aggregates and complement activation on safety of biopharmaceuticalsPrincipal Investigator
- Principal Investigator
  
  Shibata Hiroko
- Project Period (FY)
  2017 – 2019
- Research Category
  
  Grant-in-Aid for Young Scientists (B)
- Research Field
  
  Medical pharmacy
- Research Institution
  National Institute of Health Sciences

All 2020 2019 2018

All Journal Article Presentation

[Journal Article] 日本薬局方の動向と分析担当者の実務対応タンパク質医薬品注射剤の不溶性微粒子試験法.2020
- Author(s)
  柴田寛子，原園景，石井明子
- Journal Title
  
  PHARM STAGE
  
  Volume: 19(10) Pages: 9-12
- Data Source
  KAKENHI-PROJECT-17K15537
[Journal Article] Recent Achievements and Current Interests in Research on the Characterization and Quality Control of Biopharmaceuticals in Japan2020
- Author(s)
  Ishii-Watabe Akiko、Shibata Hiroko、Suetomo Hiroyuki、Ikeda Yosuke、Telikepalli Srivalli、Kiyoshi Masato、Hayashi Yu、Muto Takashi、Tanaka Yukako、Ueda Satomi、Iwura Takafumi、Saitoh Satoshi、Aoyama Michihiko、Harazono Akira、Hyuga Masashi、Goda Yukihiro、Torisu Tetsuo、Uchiyama Susumu
- Journal Title
  
  Journal of Pharmaceutical Sciences
  
  Volume: 109 Issue: 5 Pages: 1652-1661
- DOI
  10.1016/j.xphs.2020.01.001
- Peer Reviewed / Open Access / Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-17H03975, KAKENHI-PROJECT-17K15537
[Journal Article] Collaborative Study for Analysis of Subvisible Particles Using Flow Imaging and Light Obscuration: Experiences in Japanese Biopharmaceutical Consortium2019
- Author(s)
  Kiyoshi Masato、Shibata Hiroko、Uchiyama Susumu、Ishii-Watabe Akiko
- Journal Title
  
  Journal of Pharmaceutical Sciences
  
  Volume: 108 Issue: 2 Pages: 832-841
- DOI
  10.1016/j.xphs.2018.08.006
- Peer Reviewed / Open Access
- Data Source
  KAKENHI-PROJECT-17H03975, KAKENHI-PROJECT-17K15537
[Journal Article] バイオ医薬品における凝集体及び不溶性微粒子評価法について2018
- Author(s)
  柴田寛子，木吉真人，原園景，石井明子
- Journal Title
  
  医療機器レギュラトリーサイエンス
  
  Volume: 49(11) Pages: 747-753
- NAID
  40021739521
- Data Source
  KAKENHI-PROJECT-17K15537
[Presentation] フローイメージング法によるシリコーン油滴とタンパク質凝集体／不溶性微粒子の分類における測定条件の影響2019
- Author(s)
  柴田寛子，原園景，木吉真人，石井明子
- Organizer
  日本薬学会第140年会
- Data Source
  KAKENHI-PROJECT-17K15537
[Presentation] Current status and issues of biopharmaceuticals from regulatory perspective2019
- Author(s)
  Shibata H, Kiyoshi M, Harazono A, Ishii-Watabe A
- Organizer
  第19回日本蛋白質科学会年会・第71回日本細胞生物学会大会　合同年次大会
- Invited
- Data Source
  KAKENHI-PROJECT-17K15537
[Presentation] 注射剤の不溶性微粒子評価に用いられる光遮蔽法とフローイメージング法の分析性能の比較：市販タンパク質医薬品注射剤の測定結果2019
- Author(s)
  柴田　寛子，木吉　真人，原園　景，石井　明子
- Organizer
  第9回レギュラトリーサイエンス学会学術大会
- Data Source
  KAKENHI-PROJECT-17K15537
[Presentation] Collaborative study for analysis of subvisible particles using flow imaging and light obscuration: experience in Japanese biopharmaceutical consortium2018
- Author(s)
  Shibata H, Kiyoshi M, Harazono A, Torisu T, Maruno T, Akimaru M, Asano Y, Hirokawa M, Ikemoto K, Itakura Y, Iwura T, Kikitsu A, Kumagai T, Mori N, Murase H, Nishimura H, Oda A, Ogawa T, Ojima T, Okabe S, Saito S, Saitoh S, Suetomo H, Takegami K, Takeuchi M, Yasukawa H, Uchiyama S, Ishii-Watabe A
- Organizer
  2018 Workshop on Protein Aggregation and Immunogenicity
- Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-17K15537
[Presentation] Evaluation of Protein Aggregates/Subvisible Particles in Therapeutic Protein Injections.2018
- Author(s)
  Shibata H
- Organizer
  CMC Strategy Forum Japan 2018
- Int'l Joint Research
- Data Source
  KAKENHI-PROJECT-17K15537

1. 内山進

# of Collaborated Projects: 0 results

# of Collaborated Products: 2 results

Shibata Hiroko 柴田 寛子

Research Projects

Research Products

Co-Researchers

Relationship between physicochemical properties of protein aggregates and complement activation on safety of biopharmaceuticalsPrincipal Investigator

Principal Investigator

Project Period (FY)

Research Category

Research Field

Research Institution

[Journal Article] 日本薬局方の動向と分析担当者の実務対応 タンパク質医薬品注射剤の不溶性微粒子試験法.2020

Author(s)

Journal Title

Data Source

[Journal Article] Recent Achievements and Current Interests in Research on the Characterization and Quality Control of Biopharmaceuticals in Japan2020

Author(s)

Journal Title

DOI

Data Source

[Journal Article] Collaborative Study for Analysis of Subvisible Particles Using Flow Imaging and Light Obscuration: Experiences in Japanese Biopharmaceutical Consortium2019

Author(s)

Journal Title

DOI

Data Source

[Journal Article] バイオ医薬品における凝集体及び不溶性微粒子評価法について2018

Author(s)

Journal Title

NAID

Data Source

[Presentation] フローイメージング法によるシリコーン油滴とタンパク質凝集体／不溶性微粒子の分類における測定条件の影響2019

Author(s)

Organizer

Data Source

[Presentation] Current status and issues of biopharmaceuticals from regulatory perspective2019

Author(s)

Organizer

Data Source

[Presentation] 注射剤の不溶性微粒子評価に用いられる光遮蔽法とフローイメージング法の分析性能の比較：市販タンパク質医薬品注射剤の測定結果2019

Author(s)

Organizer

Data Source

[Presentation] Collaborative study for analysis of subvisible particles using flow imaging and light obscuration: experience in Japanese biopharmaceutical consortium2018

Author(s)

Organizer

Data Source

[Presentation] Evaluation of Protein Aggregates/Subvisible Particles in Therapeutic Protein Injections.2018

Author(s)

Organizer

Data Source

Shibata Hiroko 柴田寛子

[Journal Article] 日本薬局方の動向と分析担当者の実務対応タンパク質医薬品注射剤の不溶性微粒子試験法.2020