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