Development of a stable chemically cross-linked erythropoietin dimer for use in the quality control of erythropoietin therapeutic products.
Anal Bioanal Chem
; 411(13): 2755-2758, 2019 May.
Article
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| MEDLINE
| ID: mdl-30972470
ABSTRACT
Erythropoietin (EPO) is a glycoprotein hormone which promotes red cell replenishment and is also a global biotherapeutic medicine widely used to treat anaemia resulting, for example, from chemotherapy. Requirements of the European Pharmacopoeia stipulate that the level of dimer must be quantified in clinical EPO products (with a limit of 2%). Quantification is hampered by the lack of reference preparations containing stable measurable levels of EPO dimer, but the reproducible generation of a stable dimerised EPO preparation is challenging. We describe here the development of a lyophilised, chemically cross-linked EPO preparation, which has good stability and may be used for calibration and system suitability assurance for the size exclusion chromatographic separation of EPO preparations. Graphical abstract.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Eritropoyetina
/
Glutaral
/
Reactivos de Enlaces Cruzados
Límite:
Humans
Idioma:
En
Revista:
Anal Bioanal Chem
Año:
2019
Tipo del documento:
Article
País de afiliación:
Reino Unido