Colorless, clear and transparent solution.
Greater than 95.0% as determined by SEC-HPLC.
Recombinant human G-CSF (rhG-CSF) is a synthetic form of G-CSF produced using recombinant DNA technology. It is used to stimulate the production of white blood cells in patients undergoing chemotherapy, bone marrow transplantation, or suffering from severe chronic neutropenia. The recombinant form is produced in bacterial or mammalian cell cultures and is identical to the naturally occurring protein in humans.
Pegylation refers to the process of attaching polyethylene glycol (PEG) chains to a molecule, in this case, G-CSF. The pegylation of G-CSF results in a longer half-life and reduced immunogenicity, allowing for less frequent dosing and improved patient compliance. Pegylated G-CSF (PEG-rhG-CSF) is administered as a single dose per chemotherapy cycle, compared to daily injections required for non-pegylated forms.
PEG-rhG-CSF is primarily used to prevent chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) in cancer patients. It has shown efficacy in reducing the incidence of these conditions, thereby minimizing the risk of infections and allowing patients to maintain their chemotherapy schedules without dose reductions or delays .