United States Pharmacopeial Convention, 12601 Twinbrook Pkwy, Rockville, Maryland, 20852, USA.
National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Hertfordshire, EN6 3QG, UK.
Pharm Res. 2022 Mar;39(3):553-562. doi: 10.1007/s11095-022-03213-1. Epub 2022 Mar 15.
Erythropoietin (EPO) is a 165 amino acid protein that promotes the proliferation of erythrocytic progenitors. A decrease in endogenous EPO production causes anemia that can be treated with recombinant Human EPO (rHuEPO).
To ensure the safety and efficacy of the rHuEPO, manufacturers must use analytical methods to demonstrate similarity across batches and between different products. To do this they need reference standards to validate their equipment and methods.
We used peptide mapping, size-exclusion chromatography, glycoprofiling, and isoelectric focusing to analyze a rHuEPO reference standard.
Characterization demonstrates that our rHuEPO reference standard meets the criteria for quality.
The rHuEPO reference standard is fit for purpose as a tool for validating system suitability and methods.
促红细胞生成素（EPO）是一种由 165 个氨基酸组成的蛋白质，可促进红细胞祖细胞的增殖。内源性 EPO 产生减少会导致贫血，可以用重组人促红细胞生成素（rHuEPO）治疗。
为了确保 rHuEPO 的安全性和有效性，制造商必须使用分析方法来证明各批次之间以及不同产品之间的相似性。为此，他们需要参考标准来验证他们的设备和方法。
我们使用肽图分析、尺寸排阻色谱、糖基化分析和等电聚焦来分析 rHuEPO 参考标准。
特性分析表明，我们的 rHuEPO 参考标准符合质量标准。
rHuEPO 参考标准适合作为验证系统适用性和方法的工具。
