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US 9,657,056 B2Granted
Integrated continuous manufacturing of therapeutic protein drug substances
AssigneeGenzyme Corporation
InventorsKonstantin Konstantinov, Rahul Godawat, Veena Warikoo, Sujit Jain
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Abstract
Provided herein are integrated continuous biomanufacturing processes for producing a therapeutic protein drug substance. Also provided are systems that are capable of continuously producing a therapeutic protein drug substance.
Claims29
An integrated and continuous process for manufacturing a therapeutic protein drug substance, the process comprising:
- (i) culturing recombinant therapeutic protein-secreting mammalian cells in a perfusion bioreactor comprising a liquid culture medium under conditions that allow the cells to secrete the recombinant therapeutic protein into the medium, and wherein substantially cell-free volumes of the medium are continuously or periodically removed from the perfusion bioreactor and directly fed from the perfusion bioreactor into a first periodic counter current chromatography system (PCCS1) without storage in a reservoir that is a tank or a sealed bag;
- (ii) capturing the recombinant therapeutic protein from the medium using the PCCS1, wherein an eluate of the PCCS1 comprising the recombinant therapeutic protein is continuously fed into a second periodic counter current chromatography system (PCCS2);
- and
- (iii) purifying and polishing the recombinant therapeutic protein using the PCCS2, wherein the purifying is performed using a resin in the PCCS2 that is different in chemical structure compared to the resin in the PCCS2 used to perform the polishing, and an eluate from the PCCS2 is the therapeutic protein drug substance;
- and
- wherein the process is integrated and runs continuously from the culturing step to the purifying and polishing step.
3 more elements
An integrated and continuous process for manufacturing a therapeutic protein drug substance comprising:
- (i) culturing recombinant therapeutic protein-secreting mammalian cells in a perfusion bioreactor comprising a liquid culture medium under conditions that allow the cells to secrete the recombinant therapeutic protein into the medium, and wherein substantially cell-free volumes of the medium are continuously or periodically removed from the perfusion bioreactor and fed from the perfusion bioreactor into a first periodic counter current chromatography system (PCCS1);
- (ii) capturing the recombinant therapeutic protein from the medium using the PCCS1, wherein an eluate of the PCCS1 comprising the recombinant therapeutic protein is continuously fed into a second periodic counter chromatography system (PCCS2);
- and
- (iii) purifying and polishing the therapeutic recombinant protein using the PCCS2, wherein the purifying is performed using a resin in the PCCS2 that is different in chemical structure compared to the resin in the PCCS2 used to perform the polishing, and an eluate from the PCCS2 is the therapeutic protein drug substance;
- wherein the process is integrated and runs continuously from the culturing step to the purifying and polishing step.
2 more elements
Dependencies are inferred from the claim text.