METHOD FOR PRODUCTION OF THERAPEUTIC PROTEIN PREPARATION, AND PREPARATION BASED ON ANTIBODIES, OBTAINED BY SUCH A METHOD Russian patent published in 2022 - IPC A61K39/395 A61K47/18 A61K47/26 

FIELD: pharmaceutics.

SUBSTANCE: invention relates to the field of pharmaceutics, namely to a method for the production of a protein preparation, which contains excipients and at least one therapeutic protein. In this case, the method includes subsequent stages of: (a) provision of a solution including the specified protein; (b) concentration of protein in the solution, using the first ultrafiltration stage; (c) diafiltration of the resulting solution with a buffer for diafiltration, which includes at least one first excipient, by means of which retentate including protein and the first excipient is obtained, while the first excipient is amino acid; (d) addition of the second excipient to retentate obtained at the diafiltration stage, while the second excipient is sugar; (e) subsequent concentration of protein in retentate at the second ultrafiltration stage in ultrafiltration equipment; and (f) addition of at least one final excipient, by means of which a protein preparation with the required concentration of protein is obtained, which includes the specified first and final excipients. At the same time, the final excipient is selected from a surfactant or a chelating agent, or any combination thereof. In this case, amino acid is histidine; the surfactant is polysorbate 80; the chelating agent is EDTA.

EFFECT: invention provides for a possibility of obtaining higher concentrations of proteins in the final composition, not affecting the yield and stability of protein.

28 cl, 24 tbl, 2 ex, 5 dwg