Abstract:
:As reported in the previous commentary (Ishii-Watabe et al., J Pharm Sci 2017), the Japanese biopharmaceutical research group is promoting collaborative multilaboratory studies to evaluate and standardize new methodologies for biopharmaceutical characterization and quality control. We have conducted the studies and held 2 annual meetings in 2018 and 2019. At the 2018 meeting, Dr. Rukman DeSilva of the U.S. Food and Drug Administration and Dr. Srivalli Telikepalli of the National Institute of Standards and Technology participated as guest speakers. At the 2019 meeting, we invited Prof. John Carpenter of the University of Colorado, Prof. Gerhard Winter and Prof. Wolfgang Friess of Ludwig Maximilian University of Munich, and Dr. Tim Menzen of Coriolis Pharma Research, as guest commentators. In both meetings, the main research topic was strategies for the characterization and control of protein aggregates/subvisible particles in drug products. Specifically, the use of the light obscuration method for insoluble particulate matter testing with reduced injection volumes, and a comparison of analytical performance between flow imaging and light obscuration were discussed. Other topics addressed included host cell protein analysis, bioassay, and quality control strategies. In this commentary, the recent achievements of the research group, meeting discussions, and future perspectives are summarized.
journal_name
J Pharm Scijournal_title
Journal of pharmaceutical sciencesauthors
Ishii-Watabe A,Shibata H,Suetomo H,Ikeda Y,Telikepalli S,Kiyoshi M,Hayashi Y,Muto T,Tanaka Y,Ueda S,Iwura T,Saitoh S,Aoyama M,Harazono A,Hyuga M,Goda Y,Torisu T,Uchiyama Sdoi
10.1016/j.xphs.2020.01.001subject
Has Abstractpub_date
2020-05-01 00:00:00pages
1652-1661issue
5eissn
0022-3549issn
1520-6017pii
S0022-3549(20)30006-Xjournal_volume
109pub_type
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