Back to Search
Start Over
[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)].
- 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.
- Subjects :
- Alefacept
Binding, Competitive
CD2 Antigens metabolism
CD58 Antigens biosynthesis
CD58 Antigens chemistry
Chromatography, High Pressure Liquid
Humans
Immunoglobulin G biosynthesis
Immunoglobulin G chemistry
Jurkat Cells
Molecular Weight
Peptide Mapping
Quality Control
Recombinant Fusion Proteins chemistry
Biotechnology methods
Recombinant Fusion Proteins biosynthesis
Subjects
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