Integrated Continuous Manufacturing of Therapeutic Protein Drug Substances
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.
1 . 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.