Quality control methods and requirements for recombinant human lymphocyte function associated antigen 3 IgG1 fusion protein (rhLFA3-IgG1) / 药学学报
Acta Pharmaceutica Sinica
; (12): 762-767, 2007.
Article
de Zh
| WPRIM
| ID: wpr-268582
Bibliothèque responsable:
WPRO
ABSTRACT
To establish methods and requirements for quality control of rhLFA3-IgG1, biological potency of rhLFA3-IgG1 was determined by CD2 molecule competitive binding assay on Jurkat cell surface. Purity of rhLFA3-IgG1 was analyzed by SEC-HPLC and IEC-HPLC. Peptide mapping was preformed by tryptic digestion and RP-HPLC after sample reduced and carboxymethylation by DTT and indoacetic acid, respectively. CHO host cell protein and Protein A residual were detected by ELISA separately. The quality control methods and requirements, such as biological potency, the physical-chemical characteristic of rhLFA3-IgG1 had been established. The methods and requirements for quality control of rhLFA3-IgG1 showed advantages of assuring the products safety and efficacy, which can be used for routine quality control of rhLFA3-IgG1.
Texte intégral:
1
Indice:
WPRIM
Sujet Principal:
Contrôle de qualité
/
Fixation compétitive
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Biotechnologie
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Cartographie peptidique
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Protéines de fusion recombinantes
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Immunoglobuline G
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Chimie
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Chromatographie en phase liquide à haute performance
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Antigènes CD2
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Antigènes CD58
Limites du sujet:
Humans
langue:
Zh
Texte intégral:
Acta Pharmaceutica Sinica
Année:
2007
Type:
Article