INTEGRATED CONTINUOUS MANUFACTURING OF THERAPEUTIC PROTEIN DRUG SUBSTANCES Russian patent published in 2018 - IPC C07K1/16 C07K1/36 C12M1/12 

FIELD: biochemistry.

SUBSTANCE: group of inventions relates to biochemistry. Disclosed is an integrated and continuous method of producing a therapeutic protein drug substance (embodiments). In one embodiment, the method comprises providing a liquid culture medium comprising a recombinant therapeutic protein that is free of cells, and feeding the liquid culture medium into a first periodic counter current chromatography system (PCCS1). In another embodiment, the method comprises culturing mammalian cells secreting a recombinant therapeutic protein in a perfusion bioreactor containing a cell-free liquid culture medium, removing the volume of said medium from the bioreactor and feeding it to PCCS1. Each method involves capturing the recombinant therapeutic protein using PCCS1, feeding the recombinant therapeutic protein containing eluate from PCCS1 into a second periodic counter current chromatography system (PCCS2) and purification, post-purification of the recombinant therapeutic protein using PCCS2, where the PCCS2 eluate is a therapeutic protein drug substance.

EFFECT: invention provides continuous and time-efficient preparation of a therapeutic protein drug substance.

58 cl, 16 dwg, 6 tbl, 3 ex