Product information
Recombinant human erythropoietin-alpha (repo-a)
Approved therapeutic usage: Anemia, kidney failure
Source: Chinese hamster ovary cells (cho)
Description:
Recombinant human erythropoietin-alpha is produced in chinese hamster ovary (cho) cells cultured with serum free medium by recombinant dna technology is a single, polypeptide chain containing 166 amino acids with methionine as start codon and having a predicted molecular mass of 21,000 dalton and apparent glycosylated molecular mass of 30,400 dalton.
Epo-alpha is purified by proprietary chromatographic techniques.
Physical appearance:
Sterile filtered white lyophilized (freeze-dried) powder.
Formulation:
Recombinant erythropoietin-alpha was lyophilized 1mg/ml with 9mg nacl, and 2mg benzyl alcohol.
Solubility:
It is recommended to reconstitute the lyophilized repoa in sterile 18mohm-cm h2o not less than 100ug/ml with benzyl alcohol 2mg/ml
Stability:
Lyophilized repo a although stable at room temperature for 8 weeks, should be stored -20 c. Upon reconstitution repo a should be stored at 4 c between 2-7 days and for future use below -18 c. For long term storage it is recommended to add a carrier protein (0.1% hsa ) and 2mg/ml benzyl alcohol.
Purity:
Greater than 98.0% as determined by:
(a) analysis by rp-hplc.
(b) analysis by reducing and non-reducing sds-page silver stained gel.
Biological activity:
Nanogen's erythropoietin is fully biologically active when compared to standard. The specific activity was measured by normocyth-aemic mice and was found to be 120,000iu/mg.
Protein content:
Protein quantitation was carried out by two independent methods:
1. Bradford uv spectroscopy
2. Analysis by rp-hplc, using a standard solution of ifn-alpha(2a) as a reference standard.
Endotoxin:
Less than 0.1 ng/ug (ieu/ug) of repo a.
Packaging:10mg,100mg,250mg glass vial
