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US 2025/0027032 A1Published application
System and methods for combined harvest and capture of a biologic
AssigneeRepligen Corporation
InventorsMichael Bransby, Philip Yuen, Westley Blacklock, Marlon Tannous, Karol Lacki, Anthony Hunt, James Peyser
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Abstract
The invention provides tangential flow filtration systems and methods for capture and harvest of a biologic product, and related compositions.
Claims25
A method for isolating a biologic product from a process fluid characterized by high cell density and/or high turbidity, comprising
- performing a capture operation by contacting the process fluid with a capture resin in a retentate fluid circuit of a filtration module for a period of time sufficient to allow binding of the biologic product to the resin;
- performing a wash operation by separating the process fluid and resin mixture into permeate and retentate fluid streams of the filtration module and recirculating the retentate fluid stream through the retentate fluid circuit for a first number of diafiltration volumes (DVs) while directing the permeate stream to a waste container outside the fluid circuit, thereby producing a clarified retentate fluid, and optionally concentrating the clarified retentate fluid in the retentate fluid circuit;
- performing an elution operation by contacting the clarified retentate fluid with a volume of elution buffer in the retentate fluid circuit for a period of time sufficient to allow disassociation of the biologic product from the resin;
- performing a harvest operation by circulating the clarified retentate fluid and resin mixture through the filtration module, thereby separating the mixture into a permeate fluid stream comprising the biologic product and a retentate stream comprising the resin;
- and
- recirculating the retentate fluid stream through the retentate fluid circuit for a second number of DVs while directing the permeate stream to a recovery container outside the fluid circuit, thereby isolating the biologic product in the recovery container.
3 more elements
A tangential flow filtration (TFF) module comprising
- a filter medium of a nonwoven polypropylene/polyethylene polymer in the form of a flat sheet spiral wound into a tubular form and having a pore size of from 50-200 microns, a porous wall having a thickness of from 0.1 to 0.5 mm defining a lumen having an internal diameter (ID) of from 1-12 millimeters, a porosity of from about 60-90%, and a pore rating of 40, 50, 100, 150, or 200 microns, and
- a housing adapted to separate a process fluid into permeate and retentate fluid streams as it flows through the filter medium, the housing provided with an inlet, a permeate outlet and a retentate outlet.
A system for isolating a biologic product from a process fluid characterized by high cell density and/or high turbidity, comprising
- a process vessel containing the process fluid,
- at least one tangential flow filtration (TFF) module in fluid communication with the process vessel, the filtration module comprising
- a filter medium of a nonwoven polypropylene/polyethylene polymer in the form of a flat sheet spiral wound into a tubular form and having a pore size of from 50-200 microns, a porous wall having a thickness of from 0.1 to 0.5 mm defining a lumen having an internal diameter (ID) of from 1-12 millimeters, a porosity of from about 60-90%, and a pore rating of 40, 50, 100, 150, or 200 microns, and a housing adapted to separate a process fluid into permeate and retentate fluid streams as it flows through the filter medium, the housing provided with an inlet, a permeate outlet and a retentate outlet,
- a recirculation loop comprising flexible tubing interconnected between the process vessel and the TFF module to form a retentate fluid circuit, and
- at least one pump.
2 more elements
Dependencies are inferred from the claim text.