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US 12,110,312 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.
Claims14
A process for manufacturing a recombinant therapeutic protein drug substance, the process comprising:
- (a) introducing one or both of liquid culture medium or nutrients into a cell culture disposed in a perfusion bioreactor, wherein cells in the cell culture secrete a recombinant therapeutic protein;
- (b) monitoring cell density in the cell culture disposed in the perfusion bioreactor;
- (c) continuously flowing the cell culture from the perfusion bioreactor into a cell retention system;
- (d) continuously removing a liquid comprising the recombinant therapeutic protein that is substantially free of cells from the cell retention system;
- (e) feeding the liquid into a first multi-column chromatography system (MCCS);
- (f) capturing the recombinant therapeutic protein in the liquid using the first MCCS;
- and
- (g) purifying and polishing the recombinant therapeutic protein using a second MCCS, wherein the purifying is performed using a resin in the second MCCS that is different in chemical structure compared to the resin in the second MCCS used to perform the polishing.
5 more elements
Dependencies are inferred from the claim text.