earticle

영어

Biosimilar recominant DNA products have been developing actively as medicines along with the growth of biotechnology. The difficult availability of original drugs as reference materials can be the technical barrier in biosimilar development. In this study, the applicability of international and national standards as original drug substitutes was reviewed throug mass spectometry-based characterization. We established characterization testing method using LC-MS and MALDI-TOF-MS. International/national standards and reference products of somatropin and granulocyte colony-stimulating factor(G-CSF) were used to analyze molecular weight measurement, peptide profiling, peptide mapping and disulfide bond identification by LC-MS. And N-glycans extracted from erythropoietin(EPO) included in International/national standards and reference products were used to obtain distribution information about sialyation, antennary, fucosylation, phosphorylation modificaiton, and O-acetylation modification by MALDI-TOF-MS. This study showed international and national standards can replace original drugs as reference materials in characterization of non-glycoprotein drugs, but it is difficult for glycoprotein drugs because of their glycosylation difference.