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US 9,650,412 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.
Claims26
A biological manufacturing system for obtaining a recombinant therapeutic protein in a fluid, comprising:
- a first periodic counter current chromatography system (PCCCS1) comprising an inlet;
- and
- a second periodic counter current chromatography system (PCCCS2) comprising an outlet, wherein
- the PCCCS1 and the PCCCS2 are in fluid communication with each other;
- the biological manufacturing system is configured such that the fluid is passed into the inlet, through the PCCCS1 and the PCCCS2, and exits the biological manufacturing system through the outlet;
- the PCCCS1 is configured to perform at least the unit operation of capturing the recombinant therapeutic protein by a resin;
- and
- the PCCCS2 is configured to perform at least two unit operations of purifying and polishing the recombinant therapeutic protein by resins, wherein the resin used in purifying is different in chemical structure compared to the resin used in the polishing.
5 more elements
A biological manufacturing system for obtaining a recombinant therapeutic protein in a fluid, comprising two or more subsystems, wherein each of the two or more subsystems comprises:
- (i) a first periodic counter current chromatography system (PCCCS1) comprising an inlet;
- and
- (ii) a second periodic counter current chromatography system (PCCCS2) comprising an outlet, wherein the PCCCS1 and the PCCCS2 are in fluid communication with each other, and wherein the biological manufacturing system is configured such that fluid can be passed into the inlet, through the PCCCS1 and the PCCCS2, and exit the biological manufacturing system through the outlet;
- wherein:
- the two or more subsystems are configured such that they are each in fluid communication with a single reservoir containing the fluid;
- the fluid from the single reservoir passes into the inlet of the two or more subsystems;
- the PCCCS1 in each of the two or more subsystems is configured to perform at least the unit operation of capturing the recombinant therapeutic protein by a resin;
- and
- the PCCCS2 in each of the two or more subsystems is configured to perform at least two unit operations of purifying and polishing the recombinant therapeutic protein by resins, wherein the resin used in purifying is different in chemical structure compared to the resin used in the polishing.
6 more elements
Dependencies are inferred from the claim text.