演題概要

ポスター発表

第1日　5月17日（水）　　P会場（多目的ホール）

1P-55　　PDF

Protein L 精製及びLC/MS/MSを組み合わせた手法によるヒト血清中抗体医薬品のバイオアナリシス

(¹国立衛研・ ²Ig-M・ ³味の素・ ⁴ＬＳＩメディエンス・ ⁵シミックファーマサイエンス・ ⁶武田薬品・ ⁷東和薬品)
^o橋井則貴¹・ 蛭田葉子¹・ 東阪嘉子¹・ 秦信子²・ 山田尚之³・ 板屋寛³・ 菊池慶実³・ 新井浩司⁴・ 星野雅輝⁴・ 新田真一郎⁴・ 若林弘樹⁴・ 中井恵子⁴・ 後藤理恵子⁵・ 寺村俊夫⁵・ 清水久夫⁶・ 藤田央⁶・ 神野文宏⁶・ 笹原里美⁷・ 立木秀尚⁷・ 鈴木琢雄¹・ 香取典子¹・ 斎藤嘉朗¹・ 石井明子¹

Liquid chromatography/tandem mass spectrometry (LC/MS/MS) is becoming an important approach for therapeutic antibody assays as an alternative to the ligand-binding assay method. However, a bioanalytical method using LC/MS/MS includes complicated sample preparation processes, such as affinity purification and enzymatic digestion. In this study, we developed an accessible bioanalytical method using LC/MS/MS to quantify a therapeutic antibody in human serum. The method uses a versatile protein L affinity purification process and SIL-Fab as the internal standard. This method was validated in the range of 0.05–50 μg/ml with a precision and accuracy of 14.6% and 101.6%, respectively, for the lower limit of quantification sample (0.05 μg/ml). We believe that this method will be useful as a template method for bioanalysis of therapeutic antibodies in human serum.