Back to results
US 10,711,034 B2Granted
Integrated continuous manufacturing of therapeutic protein drug substances
AssigneeGenzyme Corporation
InventorsKonstantin Konstantinov, Rahul Godawat, Veena Warikoo, Sujit Jain
Life of this patent
Estimating the term…
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.
Claims17
A process for manufacturing a drug substance comprising a recombinant α-galactosidase-A, the process comprising:
- (a) culturing cells in a perfusion bioreactor comprising a liquid culture medium under conditions that allow the cells to secrete the recombinant α-galactosidase-A into the medium, wherein at least 90% cell-free volumes of the medium are continuously or periodically removed from the perfusion bioreactor and fed into a periodic counter current chromatography system (PCCS);
- (b) capturing the recombinant α-galactosidase-A from the medium using a hydrophobic interaction and anion exchange resin in the PCCS;
- and
- (c) further purifying and polishing the recombinant α-galactosidase-A by performing, sequentially, hydrophobic interaction chromatography, viral inactivation, cation exchange chromatography, and affinity chromatography, to yield the drug substance.
1 more element
Dependencies are inferred from the claim text.