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US 2024/0417427 A1Published application
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.
Claims1
An integrated and continuous process for manufacturing a therapeutic protein drug substance, the process comprising:
- (i) providing a liquid culture medium comprising a recombinant therapeutic protein that is substantially free of cells, wherein the liquid culture medium is fed into a first multi-column chromatography system (MCCS1);
- (ii) capturing said recombinant therapeutic protein in the liquid culture medium using the MCCS1, wherein the eluate of the MCCS1 containing the recombinant therapeutic protein is continuously fed into a second multi-column chromatography system (MCCS2);
- and
- (iii) purifying and polishing the recombinant therapeutic protein using the MCCS2, wherein the eluate from the MCCS2 is a therapeutic protein drug substance;
- and
- wherein the process is integrated and runs continuously from said liquid culture medium to the eluate from the MCCS2 that is the therapeutic protein drug substance.
3 more elements
Dependencies are inferred from the claim text.