Granulocyte-Colony Stimulating Factor Pegylated Human Recombinant

Lyophilized powder at room temperature.

Granulocyte Colony Stimulating Factor Human Recombinant produced in E.coli is a single, non-glycosylated, polypeptide chain containing 175 amino acids and having a molecular mass of 18.8kDa. The Pegylated G-CSF is produced by attaching a 20kDa methoxypolyethylene glycol propionaldehyde (mPEG-ALD) to the N-terminal amino acid of G-CSF giving a total molecular mass of 38.8kDa. G-CSF is purified by proprietary chromatographic techniques.
Physical Appearance and Stability: G-CSF PEG should be stored refrigerated at 2C to 8C. Vials should be kept in theirpackaging to protect from light until the time of use. Shaking and freezing should be avoided.
Formulation and Purity: G-CSF is supplied in solution (0.69mg/ml) containing 10mM Acetate Buffer (pH 4.0), and 0.004% Polysorbate 80. Greater than 95.0% as determined by SEC-HPLC.
Biological Activity: The ED50, calculated by the dose-dependent proliferation of murine NFS-60 indicator cells is less than 0.1 ng/ml, corresponding to a Specific Activity of 10, 000, 000IU/mg.