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[Quality control methods and requirements for recombinant human lymphocyte function associated antigen 3 IgG1 fusion protein (rhLFA3-IgG1)].

[Quality control methods and requirements for recombinant human lymphocyte function associated antigen 3 IgG1 fusion protein (rhLFA3-IgG1)].

Authors :
Gao K
Han CM
Ding YX
Hou S
Rao CM
Wang JZ
Source :
Yao xue xue bao = Acta pharmaceutica Sinica [Yao Xue Xue Bao] 2007 Jul; Vol. 42 (7), pp. 762-7.
Publication Year :
2007

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.

Details

Language :
Chinese
ISSN :
0513-4870
Volume :
42
Issue :
7
Database :
MEDLINE
Journal :
Yao xue xue bao = Acta pharmaceutica Sinica
Publication Type :
Academic Journal
Accession number :
17882962