Patent ID: 11884703
Assignee: GENZYME CORPORATION
Field: Chemical engineering (Chemistry)
Classification: CPC C  B | IPC B  C

Claim 9:
10. An integrated and continuous process for manufacturing a therapeutic protein drug substance, the process comprising:
(a) providing a liquid culture medium comprising the recombinant therapeutic protein that is substantially free of cells, wherein the liquid culture medium is fed into a first multi-column chromatography system (MCCS1);
(b) capturing the 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);
(c) purifying and polishing the recombinant therapeutic protein using the MCCS2, wherein the eluate from the MCCS2 is a fluid comprising the recombinant therapeutic protein;
(d) processing the fluid comprising the recombinant therapeutic protein using a method of claim 1 to produce the filtrate comprising the recombinant therapeutic protein,
wherein the process is integrated and runs continuously from the liquid culture medium of step (a) to the filtrate comprising the recombinant therapeutic protein, wherein the filtrate comprising the recombinant therapeutic protein is the therapeutic protein drug sub stance.