NEW METHOD FOR STABILIZATION OF A BIOPHARMACEUTICAL MEDICINAL PRODUCT IN MANUFACTURE THEREOF Russian patent published in 2021 - IPC A61K39/395 A61K47/18 A61K47/26 A61K9/19 

FIELD: biopharmaceuticals.

SUBSTANCE: invention relates to a method of manufacture of a biopharmaceutical medicinal product containing the biomolecule of interest, wherein the method includes: (a) the first phase of manufacture of drug substance from the biomolecule of interest wherein said first phase includes at least one preparation stage chosen from harvest, enrichment wherein said at least one preparation stage in this first phase is conducted with a composition containing at least three amino acids wherein the combination of said at least three amino acids provides for at least one positively charged functional group, at least one antioxidant functional group, at least one osmolyte function and at least one buffer function; and (b) the second phase of further preparation of the drug substance developed in (a) to produce a biopharmaceutical medicinal product, wherein said second phase includes at least one preparation stage chosen from (b1) buffer replacement, (b2) freezing, (b3) unfreezing and (b4) filling; wherein at least one preparation stage at this second phase is conducted with a composition containing (i) at least three amino acids, wherein the combination of said at least three amino acids provides for at least one positively charged functional group, at least one antioxidant functional group, at least one osmolyte function and at least one buffer function; and (ii) one or several sugars, wherein the amino acid/sugar ratio is between 10:1 and 1:100 (in mass).

EFFECT: invention enables manufacture of a biopharmaceutical medicinal product containing the biomolecule of interest.

14 cl, 7 tbl, 30 dwg