DEFINITION

Filgrastim is a recombinant form of human granulocyte colony-stimulating factor (r-metHuG-CSF). It is a single chain, 175 amino acid nonglycosylated polypeptide produced by Escherichia coli bacteria transfected with a gene encoding a methionyl human granulocyte colony-stimulating factor. When prepared as a drug substance, it contains NLT 0.9 mg/mL of Filgrastim. Formulation contains one or more suitable buffering and/or stabilizing agents. The presence of host cell DNA and protein in Filgrastim is process-specific. The capability of the process to clear host-derived DNA and protein requires validation and is determined by validated methods. It has a biological potency of NLT 80% and NMT 125% relative to standard on a mass-to-mass basis.