The stages in standardizing erythropoietin preparations

Abstract

Preparations of recombinant human erythropoietin (rhEPO) are included in the list of vital and essential drugs for medical use. When evaluating the quality of EPO preparations during the manufacturing process, under the state marketing authorization and certification procedures, in order to confirm their quality in terms of assay (specific activity), identification, dimer and high-molecular related substances content, sialic acids, it is required to use erythropoietin reference standard. The present article describes various stages of the development of erythropoietin reference standards. It provides the comparative description of the existing methods for evaluating the quality of erythropoietin preparations using reference standards. The necessity of the development and validation of national erythropoietin reference standard is justified.

Keywords

• препараты эритропоэтина
• показатели качества
• биологическая активность
• метод оценки
• точность определения
• разработка и аттестация стандартного образца
• erythropoietin preparations
• quality indicators
• biological activity
• methods of evaluation
• accuracy of determination
• development and certification of a reference standard