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4. Specification of Etanercept
| Items | Specification | Results |
| Protein content | ≥30.00mg/ml | 37.24mg/ml |
| Biological activity | ≥8.0*104AU /mg | 10.8 *104AU /mg |
Purity by Electrophoresis | Purity of monomer ≥88% Content of large molecules ≤6.0% Content of small molecules ≤8.0% | Monomer: 98.2% Large molecular: 1.4% Small molecular: 0.4% |
| Purity by SEC-HPLC | ≥95.0% | 97.8% |
| Purity by RP-HPLC | ≥95.0% | 100.0% |
| Molecular weight | 63.0~77.0 kDa | 69.6 kDa |
| UV absorption | Max. at 280nm±3nm | 279.6nm |
| Isoelectric Point | 4.8±0.5, Identical to the reference stanard | complies |
| Content of Sialic acid | 100%±30%of that of the reference standard | 106% |
| Residue of exogenous DNA | ≤100pg/25mg protein | complies |
| residue of CHO host cell protein | ≤0.03% of total protein | 0.00107% |
| Bacterial endotoxin | <2EU/mg protein | <1EU/mg protein |
| Peptide map | Identical to that of reference standard | complies |
| residue of rProtein A | not more than 0.01% of total protein | complies |
| Sequence of 15 Amino Acide at N-terminal | Leu Pro Ala Gln Val Ala Phe Thr Pro Tyr Ala Pro Glu Pro Gly | |
| Conclusion | The quality of this batch bulk product complies with Speicification | |
5. Functions
It mainly for the treatment of RA(Rheumatoid Arthritis), AS(Ankylosing Spondylotis), PS( Psoriasis), Etanercept can combine with too much inflammatory agents ( Tumor Necrosis Factor TNF) effectively. and control inflammation.
RA is a form of arthritis, is considered as a systemic autoimmune disease. RA affects multiple joints of the body, most commonly small joints of hands, wrists and feet. In RA, the joints are often affected in a fairly symmetrical fashion. Joints become painful, stiff and swollen. The recurrent attacks of RA lead to destruction of joints and loss of function, finally causing disability, which greatly affects lives of patients.
AS a chronic and progressive disease. Symptoms of the disease are typically pain and stiffness in the joints of spine in the morning on waking and ligamentous ossification which would cause “bamboo spine” and deformity of the spine.
6. About cooperation
As a high-tech content biological agents, sincerely we can delevop successful long-term cooperation for etantercept preparation. we can support each other
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Sinoway's Advantages:
(1) ISO 9001:2008 certificated company
(2) 26 years in pharmaceutical industry
(3) China office of Fischer Chemicals AG (Switzerland)
Etanercept