HIGHLY CONCENTRATED COMPOSITIONS OF ANTIBODIES TO C5 Russian patent published in 2023 - IPC A61K39/395 A61K9/08 A61K47/18 A61K47/22 A61K47/26 C07K16/18 

FIELD: biotechnology.

SUBSTANCE: group of inventions relates to stable aqueous solutions containing an antibody to C5 in a high concentration and methods for the production of these solutions. The stable aqueous solution contains an antibody to C5 at a concentration of 100 mg/ml ± 5%, 50 mM ± 5% of a phosphate buffer, 5% ± 5% of sucrose. In another option, the solution also contains 0.05% ± 5% of polysorbate 80. The antibody to C5 contains a heavy chain with SEQ ID NO: 14 and a light chain with SEQ ID NO: 11. Methods for the treatment or prevention of disorders associated with C5 complement system, such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic-uremic syndrome (aHUS), using these solutions, are also proposed. Therapeutic kits containing the specified solution and a means for administration of the solution to a patient who needs treatment are also presented.

EFFECT: invention provides a stable highly concentrated aqueous solution of an antibody to C5, which remains for at least 97% monomeric and preserves at least 90% of its C5-binding activity during storage at 2-8°C for at least six months.

27 cl, 53 dwg, 23 tbl, 3 ex