PEG-rhG-CSF

Description:
PEG-G-CSF(Pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. G-CSF is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). G-CSF is obtained from the bacterial fermentation of a strain of Escherichia coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of G-CSF. The average molecular weight of pegfilgrastim is approximately 39 kD.
Quality Control:
  Biological Activity: PEG-G-CSF is fully biologically active when compared to standard. The ED50, calculated by the dose-dependant proliferation of murine NFS-60 indicator cells (measured by 3H-thymidine uptake) is less then 0.1 ng/ml, corresponding to a Specific Activity of 1 x 108 IU/mg.