Analysis of Recombinant Human Parathyroid Hormone by In Vitro Bioassay and Chromatographic Methods

作者:Maldaner Fernanda P. S.; Xavier Bruna; Perobelli Rafaela F.; Remuzzi Gabriel L.; Motta Luis G. J.; Dalmora Sergio L.*
来源:Latin American Journal of Pharmacy, 2018, 37(3): 616-621.

摘要

Recombinant human parathyroid hormone (rhPTH 1-34) is an anabolic agent that induces bone formation, and it is clinically used to treat osteoporosis at high risk of fractures. The in vitro UMR-106 cell culture assay, based on the cell proliferation, or on the ALP activity, was applied in conjunction with validated RP-LC, SE-LC and CZE methods to evaluate altered proteins and for the content/potency assessment, showing non-significant differences (p > 0.05). These methods combination represents an advance toward the establishment of alternative approaches, to improve quality control ensuring the therapeutic efficacy of rhPTH biotechnology-derived medicines.

  • 出版日期2018