Formulation of Neulasta® (pegfilgrastim)

Neulasta® (pegfilgrastim) is a PEGylated version of its parent molecule NEUPOGEN® (Filgrastim). This work describes the formulation development for Neulasta® (pegfilgrastim), and the analytical techniques used to monitor degradation during these studies. Stability was assessed as a function of pH, protein concentration, buffer type, tonicity modifiers and surfactant concentration under both accelerated conditions and quiescent long-term storage. The stability of Neulasta® (pegfilgrastim) to agitation and successive freeze–thaw cycles was also assessed. Neulasta® (pegfilgrastim), at a protein concentration of 10 mg/mL formulated in 10 mM acetate, pH 4.0 with 5% sorbitol and 0.004% polysorbate 20, is stable for two years stored at 2–8 °C.