STABLE LIQUID COMPOSITION OF FUSED PROTEIN WITH DOMAIN Fc IgG Russian patent published in 2019 - IPC A61K47/68 A61K47/18 A61K47/26 A61K9/00 

FIELD: biochemistry.

SUBSTANCE: group of inventions relates to a liquid formulation which contains 10 to 100 mg/ml of a protein in which the soluble extracellular domain of the vascular endothelial growth factor receptor (VEGF) and the human immunoglobulin G (IgG) Fc domain are fused; a buffer containing a histidine salt and having a pH varying from 5.7 to 6.2; sugar selected from a group consisting of 2.5 % (w/v) to 10 % (w/v) sucrose, trehalose, mannitol and glucose; and a surfactant selected from a group consisting of 0 % (w/v) to 0.1 % (w/v) polysorbate 20 and polysorbate 80, where the soluble extracellular domain of the VEGF receptor contains immunoglobulin-like domain 2 of the first VEGF receptor and immunoglobulin-like domain 3 of the second VEGF receptor and the histidine salt is from 10 mM to 50 mM histidine HCl or histidine acetate. Group of inventions also relates to a composition for protein stabilization, as well as to a liquid composition containing a composition for protein stabilization and aflibercept.

EFFECT: group of inventions improves therapeutic effects on ophthalmic diseases caused by abnormal angiogenesis by providing preservation of bioactivity by stabilizing a liquid formulation suitable for intravitreal injection of a fusion protein anti-VEGF-Fc, including aflibercept, and also reduces production of impurities and by-products due to aggregation, fragmentation and isomerisation of a fused protein having a human immunoglobulin G (IgG) Fc domain.

6 cl, 8 dwg, 7 ex