期刊
PHARMACEUTICAL RESEARCH
卷 28, 期 2, 页码 386-393出版社
SPRINGER/PLENUM PUBLISHERS
DOI: 10.1007/s11095-010-0288-2
关键词
biosimilar; immunogenicity; protein characterization; recombinant human erythropoietin
资金
- Roche
- Hospira
- Organon
- Merck-Serono
To compare the quality of therapeutic erythropoietin (EPO) products, including two biosimilars, with respect to content, aggregation, isoform profile and potency. Two original products, Eprex (epoetin alfa) and Dynepo (epoetin delta), and two biosimilar products, Binocrit (epoetin alfa) and Retacrit (epoetin zeta), were compared using (1) high performance size exclusion chromatography, (2) ELISA, (3) SDS-PAGE, (4) capillary zone electrophoresis and (5) in-vivo potency. Tested EPO products differed in content, isoform composition, and potency. Of the tested products, the biosimilars have the same or even better quality as the originals. Especially, the potency of originals may significantly differ from the value on the label.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据