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US 12,760,064 B2Granted
Continuous production of recombinant proteins
AssigneeGenzyme Corporation
InventorsMichael Coolbaugh, Tarl Vetter, Chad Varner, Kevin Brower
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Abstract
The present disclosure relates to methods and systems for the continuous production of recombinant proteins. In particular embodiments, the disclosure relates to methods and systems using capture chromatography, post-capture chromatography, virus filtration, and ultrafiltration/diafiltration for the continuous production of recombinant proteins.
Claims23
A manufacturing system for producing a recombinant protein, the manufacturing system comprising:
- (a) a first unit operation subsystem comprising a bioreactor comprising host cells that produce the recombinant protein;
- (b) a second unit operation subsystem comprising one or a plurality of capture chromatography systems;
- (c) a third unit operation subsystem comprising one or a plurality of post-capture chromatography systems;
- and
- (d) a fourth unit operation subsystem comprising an ultrafiltration system and diafiltration system;
- wherein each unit operation subsystem is physically connected from the first unit operation subsystem to the fourth unit operation subsystem, and wherein the connected unit operation subsystems are configured to perform a continuous flow process comprising flowing the recombinant protein from the first unit operation subsystem to the fourth unit operation subsystem continuously;
- and
- wherein the ultrafiltration system is configured to perform single-pass tangential flow filtration and the diafiltration system is configured to perform single-pass diafiltration, and wherein the diafiltration system is configured to perform in-line buffer exchange.
5 more elements
Dependencies are inferred from the claim text.