Capillary zone electrophoresis method for a highly glycosylated and sialylated recombinant protein: development, characterization and application for process development.
Anal Chem
; 87(1): 470-6, 2015 Jan 06.
Article
em En
| MEDLINE
| ID: mdl-25521063
ABSTRACT
A purity method based on capillary zone electrophoresis (CZE) has been developed for the separation of isoforms of a highly glycosylated protein. The separation was found to be driven by the number of sialic acids attached to each isoform. The method has been characterized using orthogonal assays and shown to have excellent specificity, precision and accuracy. We have demonstrated the CZE method is a useful in-process assay to support cell culture and purification development of this glycoprotein. Compared to isoelectric focusing (IEF), the CZE method provides more quantitative results and higher sample throughput with excellent accuracy, qualities that are required for process development. In addition, the CZE method has been applied in the stability testing of purified glycoprotein samples.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Polissacarídeos
/
Bioensaio
/
Proteínas Recombinantes
/
Glicoproteínas
/
Eletroforese Capilar
/
Ácido N-Acetilneuramínico
Limite:
Humans
Idioma:
En
Revista:
Anal Chem
Ano de publicação:
2015
Tipo de documento:
Article
País de afiliação:
Estados Unidos