相对分子质量测定作为单抗药物常规放行分析方法的可行性商榷

目的:探讨十二烷基磺酸钠-聚丙烯酰胺凝胶电泳(SDS-PAGE)作为单克隆抗体常规放行分析方法的适用性。方法:对5种国产单克隆抗体药物进行SDS-PAGE法测定相对分子质量,并与质谱法测得的精确相对分子质量进行比较。结果:SDS-PAGE法测定时,采用不同的marker和不同的拟合方程,得出的相对分子质量具有较大的差异,并且与质谱法测得的精确相对分子质量具有一定的差异。结论:运用SDS-PAGE测定相对分子质量作为单抗的常规放行分析方法值得进一步商榷,应用质谱法在前期产品开发和质量控制过程对精确相对分子质量进行跟踪检测具有更准确的特点。

Objective:To explore the applicability of sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE)as the analytical method for regular release determination of Mabs. Methods:Relative molecular mass of five domestic monoclonal antibody drugs was determinated with the methods of SDS-PAGE and LC-MS.Results:With the methods of SDS-PAGE,we found great differences caused by different markers and different fitting equations,and the refative molecular mass was different from which determinated by MS.Conclusion:The SDS-PAGE method needs to be further discussion for determination of relative molecular mass.Meanwhile,application of mass spectrometry in development and quality control process in the early stage of the products is more accurate for the supervision of actual relative molecular mass detection.

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