Title:Comprehensive Analysis of Purity and Glycosylation Status of Chinese Marketed Recombinant and Urinary FSHs
Volume: 16
Issue: 6
Author(s): Yanbin Wang, Huan Shen*, Li Jiang, Shuo Chen and Ning Chen
Affiliation:
- Department of Reproductive Medical Center, Peking University People's Hospital, Peking University, Beijing,China
Keywords:
Follicle-stimulating hormones, recombinant, urinary, purity, glycosylation, protein components.
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.
