Recent Achievements and Current Interests in Research on the Characterization and Quality Control of Biopharmaceuticals in Japan
Recent Achievements and Current Interests in Research on the Characterization and Quality Control of Biopharmaceuticals in Japan
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日本生物制药表征和质量控制研究的最新成就和当前兴趣
DOI：
10.1016/j.xphs.2020.01.001
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发表时间：
2020
影响因子：
3.8
通讯作者：
U
中科院分区：
文献类型：
--
作者：
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;U
正如之前的评论（Ishii-Watabe 等人，J Pharm Sci 2017）中所报道的，日本生物制药研究小组正在促进多实验室协作研究，以评估和标准化生物制药表征和质量控制的新方法。我们进行了这项研究，并于2018年和2019年举办了2次年会。2018年的会议上，美国食品药品监督管理局的Rukman DeSilva博士和美国国家标准与技术研究院的Srivalli Telikepalli博士作为演讲嘉宾参加。在2019年的会议上，我们邀请了科罗拉多大学的John Carpenter教授、慕尼黑路德维希马克西米利安大学的Gerhard Winter教授和Wolfgang Friess教授以及Coriolis Pharma Research的Tim Menzen博士作为特邀评论员。在这两次会议中，主要研究主题是药品中蛋白质聚集体/亚可见颗粒的表征和控制策略。具体来说，讨论了使用光遮蔽方法在减少进样量的情况下进行不溶性颗粒物测试，以及流成像和光遮蔽之间的分析性能比较。其他讨论的主题包括宿主细胞蛋白质分析、生物测定和质量控制策略。在这篇评论中，总结了研究组的近期成果、会议讨论和未来展望。
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.