1B-O1-1445 PDF
液体クロマトグラフィー/質量分析によるバイオ医薬品のバイオアナリシス
Recently, liquid chromatography/mass spectrometry (LC/MS) is becoming one of the most important techniques for bioanalysis of large molecules, including biopharmaceuticals. The bioanalytical method validation (BMV) guideline on LC/MS for small molecules and the BMV guideline on the ligand binding assay are helpful while developing a bioanalytical method for large molecules using LC/MS; however, both guidelines do not contain inherent characteristics related to bioanalysis of large molecules by LC/MS. Hence, it is important to deepen discussions about issues and actions regarding bioanalysis of large molecules by LC/MS. The current status and issues regarding bioanalysis of large molecules by LC/MS are described in this presentation.