ANTIBODY CONTAINING PREPARATION Russian patent published in 2021 - IPC A61K39/395 A61P7/04 

FIELD: medicine.

SUBSTANCE: group of inventions relates to medicine and concerns an antibody-containing composition in the form of a solution with a pH of 4.5 to 6.5 for the treatment of diseases that develop and/or progress due to a decrease or deficiency in the activity of FVIII and/or activated blood coagulation factor VIII, which contains a bispecific antibody at a concentration of 20 to 180 mg/ml, in which the first polypeptide and the third polypeptide form a pair, and the second polypeptide and the fourth polypeptide form a pair, wherein the first polypeptide contains an H chain, containing the amino acid sequences of CDRs 1, 2 and 3 of the H-chain having SEQ ID NO: 1, 2 and 3 (CDR of the H-chain Q499), respectively, the second polypeptide contains the H-chain containing the amino acid sequences of CDRs 1, 2 and 3 H- chains having SEQ ID NO: 4, 5 and 6 (H chain CDR J327), respectively, and the third polypeptide and the fourth polypeptide contain a common L chain containing the amino acid sequences of the L chain CDRs 1, 2 and 3 of SEQ ID NO: 7 8 and 9 (CDR of L-chain L404), respectively, histidine / aspartate buffer at a concentration of 20 mM, poloxamer 188 at a concentration of 0.2 to 1 mg / ml, and arginine at a concentration of 100 to 300 mM. The group of inventions also relates to a method for stabilizing an antibody in an antibody-containing composition in the form of a solution, which includes the addition of histidine/aspartate buffer, poloxamer 188 and arginine to the solution, a method for suppressing the formation of antibody aggregates in an antibody-containing composition in the form of a solution, which includes the addition of histidine / aspartate buffer, poloxamer 188 and arginine to solution.

EFFECT: group of inventions provides improved stability of antibodies in solution.

12 cl, 9 ex, 2 dwg, 9 tbl