METHOD OF OBTAINING PURIFIED HETEROLOGOUS IMMUNOGLOBULIN AGAINST EBOLA FEVER Russian patent published in 2024 - IPC A61K35/12 A61K35/66 A61K35/76 A61K39/12 A61K39/395 A61K39/42 

FIELD: biotechnology.

SUBSTANCE: invention relates to a method of producing highly purified heterologous liquid immunoglobulin against Ebola fever. A method of producing highly purified heterologous liquid immunoglobulin against Ebola fever from horse blood serum, including preparing an antigen from a virulent strain of the Ebola virus, obtaining immune blood, obtaining immune serum using a 30% calcium chloride solution, isolating immunoglobulin, purifying and concentrating by chromatography, packaging and packing characterized by the following: the isolation of immunoglobulin from horse immune serum is carried out by the precipitation method by adding ammonium sulphate, the purification of the immunoglobulin is carried out in two stages, for the first stage of purification affinity chromatography is used on the Protein G sorbent at a sample feed rate of 60 cm⋅h^-1 followed by elution at a flow rate of 100 cm⋅h^-1 100 mM glycine solution, pH 2.7; for the second stage, gel filtration chromatography is used on Superdex 200 sorbent with protein separation in isocratic elution mode with phosphate-buffered saline, pH 7.2, at a flow rate of 50 cm⋅h^-1.

EFFECT: use of the invention ensures the production of purified equine Ebola immunoglobulin with a high content of the monomeric fraction of immunoglobulin (at least 97%) and the amount of foreign fractions of dimers, polymers and aggregates (not more than 3%), which reduces the anaphylactogenicity of the immunoglobulin (anaphylactogenicity index≤ 1.0) and brings the quality of the medicinal product in compliance with the requirements of the European Pharmacopoeia for heterologous medicinal products.

7 cl, 6 dwg, 4 tbl, 7 ex