Study on methods and requirements for quality control of recombinant human tumor necrosis factor receptor Fc fusion protein / 药学学报
Acta Pharmaceutica Sinica
;
(12): 165-168, 2003.
Article
in Chinese
| WPRIM
| ID: wpr-251151
ABSTRACT
<p><b>AIM</b>To establish methods and requirements for quality control of recombinant human tumor necrosis factor receptor Fc fusion protein (rhTNFR-Fc).</p><p><b>METHODS</b>Biological potency of rhTNFR-Fc was determined by neutralizing the bioactivity of TNF-alpha. rhTNFR-Fc samples were reduced by beta-mercaptoethanol and the peptide map was performed by tryptic digestion. Residual protein A and the host cell protein content were detected by ELISA. Anti-TNFR and anti-Fc antibodies were used in ELISA for detection of the rhTNFR-Fc content.</p><p><b>RESULTS</b>The quality control methods, such as bioassay, peptide map, residual protein A detection, were established and used for quality control of rhTNFR-Fc. The unit of rhTNFR-Fc (AU) was defined according to the international unit of TNF-alpha. The specific activity was up to 8 x 10(4) AU.mg-1. The requirements for quality control of rhTNFR-Fc were established.</p><p><b>CONCLUSION</b>The methods and requirement were used for quality control of rhTNFR-Fc products.</p>
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Pharmacology
/
Quality Control
/
Reference Standards
/
Biotechnology
/
Peptide Mapping
/
Recombinant Fusion Proteins
/
Immunoglobulin G
/
Tumor Cells, Cultured
/
Cell Division
/
Chemistry
Limits:
Animals
Language:
Chinese
Journal:
Acta Pharmaceutica Sinica
Year:
2003
Type:
Article
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