METHOD FOR PRODUCING A HIGHLY PURIFIED RECOMBINANT HUMAN C1-ESTERASE INHIBITOR FOR APPLICATION IN MEDICINE Russian patent published in 2022 - IPC C07K14/81 C07K1/36 A61K38/57 

FIELD: pharmaceuticals.

SUBSTANCE: group of inventions relates to a method for purifying a recombinant human C1-esterase inhibitor and to an application of the method for producing an active pharmaceutical substance of a recombinant human C1-esterase inhibitor. The proposed method for purification includes viral inactivation, metal chelate chromatography, affinity chromatography, and anion exchange chromatography. When the content of proteins of the producer strain in the product therein is less than 3,000 ng/mg and the level of DNA is less than 50 pg/mg, the product is purified by finishing hydrophobic chromatography using a sorbent containing phenyl groups. Also proposed is an application of the above method for producing an active pharmaceutical substance characterised by the content of a monomeric form of the recombinant human C1-esterase inhibitor of no less than 99.0%, the content of the main form of the recombinant human C1-esterase inhibitor based on the data of reverse-phase HPLC of at least 99.5%, the content of residual proteins of the producer strain of no more than 10 ng/mg, the content of DNA of the producer strain of no more than 5 pg/mg. The specific activity of the resulting active pharmaceutical substance is no less than 9.0 IU/mg.

EFFECT: ensured purification of a recombinant human C1-esterase inhibitor.

11 cl, 1 dwg, 6 tbl, 2 ex