Integrated Continuous Manufacturing of Therapeutic Protein Drug Substances

摘要

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.

主权项

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 periodic counter current chromatography system (PCCS1); (ii) capturing said recombinant therapeutic protein in the liquid culture medium using the PCCS1, wherein the eluate of the PCCS1 containing the recombinant therapeutic protein is continuously fed into a second periodic counter current chromatography system (PCCS2); and (iii) purifying and polishing the recombinant therapeutic protein using the PCCS2, wherein the eluate from the PCCS2 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 PCCS2 that is the therapeutic protein drug substance.