# US 2025/0083104 A1 · Low concentration single pass tangential flow filtration to de-bottleneck connected and/or high titer fed batch processes > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2025/0083104 A1 - Document ID: US20250083104A1 - Status: Published application - Kind: A1 - Application number: 18/826,764 - Filed: 2024-09-06 - Published: 2025-03-13 - Earliest claimed: 2023-09-08 - Assignees: Genentech, Inc. - Applicants: Genentech, Inc. - Inventors: Molly Carpenter LIEN; John Robert LAZZARESCHI; Jerome Joseph BILL, JR. - Web page: https://patentgrep.com/patent/US20250083104A1 ## CPC - B01D 61/146: {comprising multiple ultrafiltration steps} - B01D 61/18: Apparatus therefor - B01D 15/08: Selective adsorption, e.g. chromatography - B01D 61/145: {Ultrafiltration} - B01D 61/22: Controlling or regulating - B01D 2311/04: Specific process operations in the feed stream; Feed pretreatment - B01D 2311/16: Flow or flux control - B01D 2311/165: Cross-flow velocity control - B01D 2311/2688: Biological processes - B01D 2313/18: Specific valves - B01D 2313/243: Pumps - B01D 2315/10: Cross-flow filtration - B01D 2315/16: Diafiltration - B01D 2317/02: Elements in series - B01D 2317/022: Reject series - B01D 2317/04: Elements in parallel - B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28) ## Abstract Exemplary systems and methods are provided for receiving a feed flow at a feed flow inlet of a single pass tangential flow filtration unit, wherein the single pass tangential flow filtration unit includes one or more membranes or membrane devices in a one-or two-stage configuration, and wherein a pressure drop across the one or more membranes or membrane devices is less than or equal to 30 psi. The systems and methods are configured to separate, using the one or more membranes or membrane devices in a one-or two-stage configuration, the feed stream into a permeate stream and a retentate stream and output the permeate stream through one or more permeate outlets and the retentate stream through one or more retentate outlets. ## Claims ### Claim 1 A single pass tangential flow filtration system, the system comprising: a single pass tangential flow filtration unit configured to be fluidly connected to one or more preceding systems and one or more subsequent systems, wherein: the single pass tangential flow filtration unit comprises one or more membranes or membrane devices in a one-or two-stage configuration, and a pressure drop across the one or more membranes or membrane devices is less than or equal to 30 psi. ### Claim 2 (depends on 1) The single pass tangential flow filtration system of claim 1, wherein the pressure drop across the one or more membranes or membrane devices is less than 20 psi. ### Claim 3 (depends on 1) The single pass tangential flow filtration system of claim 1, wherein the single pass tangential flow filtration unit is configured to be connected to the one or more preceding systems by a feed flow inlet configured to receive a feed stream. ### Claim 4 (depends on 3) The single pass tangential flow filtration system of claim 3, wherein the single pass tangential flow filtration unit is configured to be connected to the one or more subsequent systems by one or more retentate flow outlets each configured to output a retentate stream. ### Claim 5 (depends on 1) The single pass tangential flow filtration system of claim 1, wherein the system is positioned on a mobile platform. ### Claim 6 (depends on 1) The single pass tangential flow filtration system of claim 1, wherein no pump is provided between the single pass tangential flow filtration unit and the one or more preceding systems. ### Claim 7 (depends on 4) The single pass tangential flow filtration system of claim 4, further comprising a controller in electrical communication with one or more sensors, the one or more sensors provided on a feed line in fluid communication with the feed flow inlet, one or more permeate lines in fluid communication with the one or more permeate outlets, and one or more retentate lines in fluid communication with the one or more retentate outlets. ### Claim 8 (depends on 7) The single pass tangential flow filtration system of claim 7, wherein the controller is configured to control a volumetric concentration factor based on a determined volumetric concentration factor. ### Claim 9 (depends on 8) The single pass tangential flow filtration system of claim 8, wherein the volumetric concentration factor is determined based on a reading from a first sensor and a second sensor of the one or more sensors. ### Claim 10 (depends on 9) The single pass tangential flow filtration system of claim 9, wherein the first sensor is a flow meter provided on the feed line in fluid communication with the feed flow inlet and the second sensor is a flow meter provided a retentate flow line of one or more retentate flow lines in fluid communication with one or more of the retentate outlets. ### Claim 11 (depends on 9) The single pass tangential flow filtration system of claim 9, wherein the volumetric concentration factor is determined based upon a ratio of a measured flow rate of the feed stream to a measured flow rate of the retentate stream, wherein the respective flow rates are measured by the first and second sensors. ### Claim 12 (depends on 9) The single pass tangential flow filtration system of claim 9, wherein the first sensor is a protein concentration sensor provided on the feed line in fluid communication with the feed flow inlet and the second sensor is a protein concentration sensor provided a retentate flow line of one or more retentate flow lines in fluid communication with one or more of the retentate outlets, and wherein the volumetric concentration factor is determined based upon a ratio of a measured protein concentration of the retentate stream to a measured protein concentration of the feed stream, wherein the respective protein concentrations are measured by the first and second sensors. ### Claim 13 (depends on 8) The single pass tangential flow filtration system of claim 8, wherein controlling the volumetric concentration factor comprises: in accordance with determining that the volumetric concentration factor is outside of a threshold range based on the determined volumetric concentration factor, adjusting a flow rate of the permeate stream to bring the volumetric concentration factor within the threshold range. ### Claim 14 (depends on 13) The single pass tangential flow filtration system of claim 13, wherein the threshold range is between 1.0 and 3.0, including 1.0 and 3.0. ### Claim 15 (depends on 13) The single pass tangential flow filtration system of claim 13, wherein the threshold range is between 1.5 and 2.5, including 1.5 and 2.5. ### Claim 16 (depends on 13) The single pass tangential flow filtration system of claim 13, wherein adjusting a flow rate of the permeate stream to bring the volumetric concentration factor within the threshold range comprises: activating or deactivating one or more permeate control pumps provided on one or more of the one or more permeate lines downstream of the one or more permeate outlets. ### Claim 17 (depends on 16) The single pass tangential flow filtration system of claim 16, wherein one or more of the permeate control pumps include one or more variable displacement pumps. ### Claim 18 (depends on 17) The single pass tangential flow filtration system of claim 17, wherein adjusting a flow rate of the permeate stream to bring the volumetric concentration factor within the threshold range comprises increasing a displacement of a variable displacement pump of the one or more variable displacement pumps. ### Claim 19 (depends on 17) The single pass tangential flow filtration system of claim 17, wherein adjusting a flow rate of the permeate stream to bring the volumetric concentration factor within the threshold range comprises decreasing a displacement of a variable displacement pump of the one or more variable displacement pumps. ### Claim 20 (depends on 16) The single pass tangential flow filtration system of claim 16, wherein one or more of the permeate control pumps include one or more fixed displacement pumps. ### Claim 21 (depends on 13) The single pass tangential flow filtration system of claim 13, wherein adjusting a flow rate of the permeate stream to bring the volumetric concentration factor within the threshold range comprises: adjusting a valve provided on one or more permeate lines downstream of the one or more permeate outlets. ### Claim 22 (depends on 21) The single pass tangential flow filtration system of claim 21, wherein adjusting the valve comprises opening the valve. ### Claim 23 (depends on 21) The single pass tangential flow filtration system of claim 21, wherein adjusting the valve comprises closing the valve. ### Claim 24 (depends on 7) The single pass tangential flow filtration system of claim 7, wherein the one or more sensors comprise a flow meter, a pressure sensor, a temperature sensor, and a protein concentration sensor. ### Claim 25 (depends on 1) The single pass tangential flow filtration system of claim 1, wherein the single pass tangential flow filtration unit comprises one or more membranes or membrane devices in a one stage configuration. ### Claim 26 (depends on 25) The single pass tangential flow filtration system of claim 25, wherein the one stage configuration is configured to receive a feed stream from the feed flow inlet and separate the feed stream into a retentate stream and a permeate stream by allowing a portion of the feed stream to pass through one or more membranes or membrane devices, the portion passing through the one or more membranes or membrane devices forming the permeate stream. ### Claim 27 (depends on 1) The single pass tangential flow filtration system of claim 1, wherein the single pass tangential flow filtration unit comprises one or more membranes or membrane devices in a two-stage configuration. ### Claim 28 (depends on 27) The single pass tangential flow filtration system of claim 27, wherein the two-stage configuration is configured to receive a feed stream from the feed flow inlet and separate the feed stream into a retentate stream and a permeate stream by allowing a portion of the feed stream to pass through one or more membranes or membrane devices of a first stage and one or more membranes or membrane devices of a second filtration stage, the portion passing through the one or more membranes of the first and second stage forming the permeate stream. ### Claim 29 (depends on 3) The single pass tangential flow filtration system claim 3 wherein the operating temperature of the feed stream is between 2 degrees Celsius and 30 degrees Celsius, including 2 degrees Celsius and 30 degrees Celsius. ### Claim 30 (depends on 3) The single pass tangential flow filtration system of claim 3, wherein the operating temperature of the feed stream is less than or equal to 20 degrees Celsius. ### Claim 31 (depends on 3) The single pass tangential flow filtration system of claim 3, wherein the operating temperature of the feed stream is less than or equal to 15 degrees Celsius. ### Claim 32 (depends on 3) The single pass tangential flow filtration system of claim 3, wherein the operating temperature of the feed stream is less than or equal to 10 degrees Celsius. ### Claim 33 (depends on 3) The single pass tangential flow filtration system of claim 3, wherein the operating temperature of the feed stream is less than or equal to 5 degrees Celsius. ### Claim 34 (depends on 3) The single pass tangential flow filtration system of claim 3, wherein the operating temperature of the feed stream is between 1 degree Celsius and 3 degrees Celsius, including 1 degree Celsius and 3 degrees Celsius. ### Claim 35 (depends on 1) The single pass tangential flow filtration system of claim 1, wherein the one or more preceding systems comprise a purification system or a harvest system. ### Claim 36 (depends on 35) The single pass tangential flow filtration system of claim 35, wherein the purification system comprises a viral filtration system. ### Claim 37 (depends on 35) The single pass tangential flow filtration system of claim 35, wherein the purification system comprises a chromatography system. ### Claim 38 (depends on 35) The single pass tangential flow filtration system of claim 35, wherein the purification system comprises a diafiltration system. ### Claim 39 (depends on 35) The single pass tangential flow filtration system of claim 35, wherein the purification system comprises an ultrafiltration system. ### Claim 40 (depends on 1) The single pass tangential flow filtration system of claim 1, wherein the one or more subsequent systems comprise a purification system. ### Claim 41 (depends on 40) The single pass tangential flow filtration system of claim 40, wherein the purification system comprises a viral filtration system. ### Claim 42 (depends on 40) The single pass tangential flow filtration system of claim 40, wherein the purification system comprises a chromatography system. ### Claim 43 (depends on 40) The single pass tangential flow filtration system of claim 40, wherein the purification system comprises a diafiltration system. ### Claim 44 (depends on 40) The single pass tangential flow filtration system of claim 40, wherein the purification system comprises an ultrafiltration system. ### Claim 45 (depends on 3) The single pass tangential flow filtration system of claim 3, wherein the feed flow comprises a polypeptide preparation. ### Claim 46 (depends on 45) The single pass tangential flow filtration system of claim 45, wherein the polypeptide preparation comprises a polypeptide and one or more impurities. ### Claim 47 A single pass tangential flow filtration method, the method comprising: receiving a feed flow at a feed flow inlet of a single pass tangential flow filtration unit, wherein the single pass tangential flow filtration unit comprises one or more membranes or membrane devices in a one-or two-stage configuration, and wherein a pressure drop across the one or more membranes or membrane devices is less than or equal to 30 psi; separating, using the one or more membranes or membrane devices, the feed stream into a permeate stream and a retentate stream; and outputting the permeate stream through one or more permeate outlets and the retentate stream through one or more retentate outlets.