HIGHLY CONCENTRATED COMPOSITIONS OF MONOCLONAL ANTIBODIES Russian patent published in 2020 - IPC A61K9/10 A61K39/395 A61K47/26 

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine and concerns suspension composition for treating a disease or disorder containing a spray-dried human monoclonal antibody IgG1 in concentration of 200 mg/ml or more, suspended in a non-aqueous excipient for suspension, viscosity of the filler for the suspension is less than 20 centipoise at 25 °C; where non-aqueous filler for suspension contains ethyl lactate. Wherein the disease or disorder is angiogenesis, a malignant tumor, an autoimmune disease, age-related macular degeneration (AMD) or macular edema; and the antibody binds to an antigen selected from a group consisting of CD20, HER2, VEGF, IL6R, beta7, A-beta, HER3, EGFR and M1'. Group of inventions also relates devices for subcutaneous administration of said composition; method of producing a suspension composition; use of said composition for treating a disease or disorder in a patient, wherein the disease or disorder is angiogenesis, malignant tumor, autoimmune disease, age-related macular degeneration (AMD) or macular edema.

EFFECT: group of inventions provides physical stability of a suspension of monoclonal antibodies human IgG1.

32 cl, 10 dwg, 4 tbl, 1 ex