Comprehensive Analysis of Purity and Glycosylation Status of Chinese Marketed Recombinant and Urinary FSHs

Abstract

Background: Urinary or recombinant Follicle-Stimulating Hormones (uFSH and rhFSH) are regularly applied in controlled ovarian stimulation procedure of assisted reproductive technology. Specific activity and purity of these reagents are of great importance since subtle variations in the contents and glycosylation status of FSH may result in differences in clinical efficacy and safety. Objective: The purpose of this study was to comprehensively analyze the FSH contents, glycosylation status and non-specific protein components of the widely used rhFSH Gonal-F and two Chinese marketed FSHs, r-FSH (JSH) and urinary-derived FSH (LSB). Methods: FSH contents, glycosylation status, and other protein contents in these FSH products were assessed with benchtop assays including SDS-PAGE, HPLC and MALDI-MS. Results: HPLC results showed that the purity of the three products was 81.5±0.06% for Gonal-F, 79.6±0.25% for LSB and 76.5±0.36% for JSH, respectively. In addition, MALDI-MS analysis demonstrated that the Gonal-F contained more types of glycosylated isoforms compared to the local rFSHs. The analytical assessment showed that the urinary-derived FSH contained several other protein components. Conclusion: These results suggest that rhFSH Gonal-F is with high purity and potential high activity.