FIELD: pharmaceutical biotechnology.
SUBSTANCE: invention relates to a method of purifying recombinant proteins, namely to obtaining romiplostim, a highly purified medicinal product. The invention is a method of purification of recombinant romiplostim obtained in E. coli including isolation and washing of inclusion bodies, protein refolding and chromatographic purification, while the main removal of contaminating impurities is carried out at the stage of isolation of inclusion bodies by sequential washing, and additional removal of impurities includes carrying out 2 consecutive stages of chromatography on the same cation-exchange sorbent, where the first stage is separating, and the second is polishing and concentrating.
EFFECT: development of a method of industrial purification of romiplostim.
7 cl, 14 dwg, 5 tbl, 2 ex
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Authors
Dates
2023-10-03—Published
2021-05-18—Filed