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US 11,884,703 B2Granted
Methods of processing a fluid including a recombinant therapeutic protein and use thereof
AssigneeGenzyme Corporation
InventorsTarl Vetter, Michael Coolbaugh, Veena Warikoo, Konstantin Konstantinov
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Abstract
Provided herein are methods of processing a fluid that include the use of one or both of a circuit system including a tangential flow filtration (TFF) unit and a circuit system including a tangential flow virus filtration (TFVF) unit. Also provided are integrated and continuous processes for manufacturing a therapeutic protein drug substance that include a step of processing a fluid including the recombinant therapeutic protein using any of the methods provided herein.
Claims20
A method of processing a fluid comprising a recombinant therapeutic protein, the method comprising:
- (a) providing a circuit system comprising (i) a tangential flow virus filtration (TFVF) unit having first and second inlets, and (ii) a conduit in fluid communication between the first and second inlets of the TFVF unit, comprising at least one port for flowing fluid into or out of, or both, of the circuit system,
- wherein the circuit system is configured such that fluid can be flowed through the conduit and the TFVF unit, and filtrate comprising the recombinant therapeutic protein can be collected from the TFVF unit;
- (b) flowing a fluid including a recombinant therapeutic protein into the circuit system through one of the at least one port, recirculating retentate in the circuit system, and collecting filtrate comprising the recombinant therapeutic protein from the TFVF unit for a period of time;
- wherein rate of recirculating the retentate in the circuit system and rate of flowing the fluid into the circuit system are independently controlled.
1 more element
Dependencies are inferred from the claim text.