Liquid formulations for long-acting G-CSF conjugate
AssigneeHanmi Science Co., Ltd.
InventorsMi Ji Lee, Jae Min Lee, Byung Sun Lee, Sung Min Bae, Se Chang Kwon
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Abstract
Disclosed is a liquid formulation which allows long-acting G-CSF conjugates, that have improved in vivo duration and stability, to be stable when stored for a long period of time. It comprises a stabilizer composition characterized by buffer and mannitol. Being free of human serum albumin and other potential factors harmful to the body, the liquid formulation is free of concerns about viral infections and guarantees excellent storage stability to long-acting G-CSF conjugates.
Claims17
A liquid formulation for a long-acting granulocyte-colony stimulating factor (G-CSF) conjugate, comprising
- a therapeutically effective amount of a long-acting granulocyte-colony stimulating factor conjugate in which G-CSF is covalently linked to an immunoglobulin Fc fragment via a non-peptide polymer or peptide linker and the immunoglobulin Fc fragment is not modified with other non-peptide polymer, and
- an albumin-free stabilizer containing citrate buffer of pH 5.5 to 8.0, polysorbate 80 and mannitol,
- wherein G-CSF is a wild type human G-CSF or a human 17Ser-G-CSF mutant in which cystein at position 17 of the wild type human G-CSF is substituted with serine, and
- wherein a concentration of the mannitol ranges from 1 to 20% (w/v) based on the total volume of the liquid formulation.
Dependencies are inferred from the claim text.