Recent Achievements and Current Interests in Research on the Characterization and Quality Control of Biopharmaceuticals in Japan-Reference-Cited by-同舟云学术

Recent Achievements and Current Interests in Research on the Characterization and Quality Control of Biopharmaceuticals in Japan

Published:2020-05 Issue:5 Volume:109 Page:1652-1661
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

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

Funder

Japan Agency for Medical Research and Development

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference15 articles.

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2. Interlaboratory comparison about feasibility of insoluble particulate matter test for injections with reduced test volume in light obscuration method;Harazono;Biologicals,2019

3. Collaborative study for analysis of subvisible particles using flow imaging and light obscuration: experiences in Japanese biopharmaceutical consortium;Kiyoshi;J Pharm Sci,2019

4. An interlaboratory comparison of sizing and counting of subvisible particles mimicking protein aggregates;Ripple;J Pharm Sci,2015

5. NIST Special Publication 260-193 “Reference Material 8634: Ethylene Tetrafluoroethylene for Particle Size Distribution and Morphology” ed. Available at: https://www.nist.gov/system/files/documents/2019/05/02/sp260-193.pdf. Accessed February 9, 2020.

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1. Comparison of Protein-like Model Particles Fabricated by Micro 3D Printing to Established Standard Particles;Journal of Pharmaceutical Sciences;2024-08

2. Roadmap for Drug Product Development and Manufacturing of Biologics;Journal of Pharmaceutical Sciences;2024-02

3. Quantitative analysis of antibody aggregates by combination of pinched-flow fractionation and coulter method;Analytical Biochemistry;2023-11

4. Plate Reader-Based Analytical Method for the Size Distribution of Submicron-Sized Protein Aggregates Using Three-Dimensional Homodyne Light Detection;Journal of Pharmaceutical Sciences;2021-12