Quality control methods and requirements for recombinant human lymphocyte function associated antigen 3 IgG1 fusion protein (rhLFA3-IgG1).
- Author:
Kai GAO
1
;
Chun-mei HAN
;
You-xue DING
;
Sheng HOU
;
Chun-ming RAO
;
Jun-zhi WANG
Author Information
1. National Institute for the Control of Pharmaceutical and Biological Products, Beijing 100050, China.
- Publication Type:Journal Article
- MeSH:
Binding, Competitive;
Biotechnology;
methods;
CD2 Antigens;
metabolism;
CD58 Antigens;
biosynthesis;
chemistry;
Chromatography, High Pressure Liquid;
Humans;
Immunoglobulin G;
biosynthesis;
chemistry;
Jurkat Cells;
Molecular Weight;
Peptide Mapping;
Quality Control;
Recombinant Fusion Proteins;
biosynthesis;
chemistry
- From:
Acta Pharmaceutica Sinica
2007;42(7):762-767
- CountryChina
- Language:Chinese
-
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.
