基于纳升电喷雾-轨道阱超高分辨质谱对完整单克隆抗体药物进行分子量测定及糖型鉴定的条件探究

整体分子量测定和糖型鉴定是抗体药物研发及生产中不可或缺的表征内容,而在完整蛋白层面进行测定可获得最为直接的测定结果。实现此类测定有赖于可提供较高分辨能力及质量精度的仪器;测定中涉及的相对复杂的参数设置可能受多种条件的干扰而产生误导性结果。该研究考察了利用纳升电喷雾离子源-轨道阱质谱仪以非变性质谱方式测定完整单克隆抗体药时,仪器分辨率、源内裂解、碰撞诱导碎裂、溶液组成等条件对单克隆抗体药物分子量及糖型测定结果的影响,以期为此类质谱分析提供有益的借鉴。

Key Parameters for Molecular Weight Determination and Glycoform Identification on Intact Therapeutic Monoclonal Antibodies by Ultra high Resolution Orbitrap Mass Spectrometry with Nanospray Ionization

Several methods were employed to explore the composition of Mongolian medicine magnetite.Fourier transform infrared spectroscopy(FTIR) and X ray diffraction(XRD) were used to determine the spectra of 10 batches of sample from different manufacturers,while elements in magnetite were quantified by inductively coupled plasma mass spectrometry(ICP-MS).Therefore,seven characteristic peaks were found in the infrared spectra for the magnetite,and the characteristic absorption peaks for quartz and Fe3O4 were at 468 cm-1 and 526 cm-1,respectively.Nine characteristic peaks were detected in XRD experiment.The data of peak 5,7,8 and 9 in the spectrum for magnetite were consistent with those of Fe3O4,while the data of the peak 3 and 4 were consistent with those of SiO2.Meanwhile,ICP-MS was used to quantify 24 elements in magnetite.Results showed that the content of Fe was found to be the highest,and other heavy metals and harmful elements were also detected.FTIR,XRD and ICP-MS could be used to identify the structure of magnetite,which lays a foundation for the quality analysis of magnetite.