earticle

영어

Granulocyte colony-stimulating factor (G-CSF) is a growth factor or that serves as a major regulator of the development of neutrophils. NEUPOGEN® (Filgrastim), a recombinant methionyl human G-CSF injected daily, was launched in 1991 for the treatment of cancer therapy-induced neutropenia and associated infections. PEGylated version of its parent molecule NEUPOGEN® is called NEULASTA® (Pegfilgrastim), which is a long-acting formulation of NEUPOGEN®. Alteogen, Inc. has developed a novel long-acting technology for extending in vivo half-lives of biodrugs using NexP fusion carrier. A CHO cell-line which stably expresses the recombinant G-CSF/NexP fusion protein was developed and after cultivation of the cell in a 10L single-use bioreactor (CELL-tainer, CELLution Biotech BV, Netherlands), we purified G-CSF/NexP fusion proteins to more than 99% purity by three chromatography steps. Rodent studies indicated that the G-CSF fused to NexP showed an increased in vivo half-life and also the duration of the long-acting activity measered by granulocyte production was substantially increased compared to that of daily G-CSF. Toxicokinetic studies of G-CSF/NexP fusion protein in rodents were alto performed.