論文掲載のお知らせ(ヒト血漿中ADCのDARおよびDLD分析法構築)

論文掲載のお知らせ(ヒト血漿中ADCのDARおよびDLD分析法構築)

 シミックファーマサイエンス株式会社の研究員が参画した、薬物動態評価に関する多機関共同研究についての論文が公開されましたので、お知らせいたします。

 シミックファーマサイエンス株式会社は、国立医薬品食品衛生研究所が主導するAMED創薬基盤推進研究事業に参画し、4種の新規モダリティ医薬品に対し薬物動態評価のための生体試料中濃度等分析法の開発・標準化に関する研究を行いました。その成果として、ヒト血漿中の抗体薬物複合体(ADC)の薬物-抗体比(DAR)および薬物負荷分布(DLD)を評価するための汎用的なインタクトLC-MS法を開発しました。
 本手法は、多機関共同研究による実行可能性評価を通じてその実用性が確認され、標準化された方法としての有効性が示されています。

 私たちの研究が、ADCの薬物動態プロファイルの理解を深め、医薬品開発に貢献することを期待しております。

著者 Noritaka Hashii, Yusuke Haruyama, Ryu Hirayama, Ryo Kajita, Yuki Kishino, Toshiki Mochizuki, Kazuko Inoue, Ryoya Goda, Masaki Hoshino, Itsuki Kuroiwa, Hiroaki Aikawa, Natsuki Ueda, Kaori Nagumo, Yuki Oda, Yoshiro Saito &Akiko Ishii-Watabe
表題 Versatile intact LC–MS method for evaluating the drug–antibody ratio and drug load distribution of antibody–drug conjugates in human plasma
雑誌 Journal of Chromatography B Volume 1258, 15 May 2025, 124608: Published online
https://www.sciencedirect.com/science/article/pii/S1570023225001606

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