# US 11,077,404 B2 · Process control systems and methods for use with filters and filtration processes > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 11,077,404 B2 - Document ID: US11077404B2 - Status: Granted - Kind: B2 - Application number: 16/743,728 - Filed: 2020-01-15 - Published: 2020-05-14 - Granted: 2021-08-03 - Earliest claimed: 2014-05-13 - Assignees: Amgen Inc. - Applicants: Amgen Inc. - Inventors: Eva Gefroh; Randolph W. Schweickart; Krista Petty; Gregory Frank; Christine Salstrom Terpsma; Arthur C. Hewig, III; Joseph Edward Shultz - Web page: https://patentgrep.com/patent/US11077404B2 ## CPC - B01D 61/22: Controlling or regulating - B01D 61/145: {Ultrafiltration} - B01D 61/149: {Multistep processes comprising different kinds of membrane processes selected from ultrafiltration or microfiltration} - B01D 61/18: Apparatus therefor - C07K 1/34: by filtration, ultrafiltration or reverse osmosis - B01D 2311/04: Specific process operations in the feed stream; Feed pretreatment - B01D 2311/06: Specific process operations in the permeate stream - B01D 2313/18: Specific valves - B01D 2313/243: Pumps - B01D 2313/501: Permeate storage tanks - B01D 2313/502: Concentrate storage tanks - B01D 2313/60: Specific sensors or sensor arrangements - B01D 2315/10: Cross-flow filtration - 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) - C07K: PEPTIDES (peptides in foodstuffs A23; obtaining protein compositions for foodstuffs, working-up proteins for foodstuffs A23J; preparations for medicinal purposes A61K; peptides containing beta-lactam rings C07D; cyclic dipeptides not having in their molecule any other peptide link than those which form their ring, e.g. piperazine-2,5-diones, C07D; ergot alkaloids of the cyclic peptide type C07D519/02; macromolecular compounds having statistically distributed amino acid units in their molecules, i.e. when the preparation does not provide for a specific; but for a random sequence of the amino acid units, homopolyamides and block copolyamides derived from amino acids C08G69/00; macromolecular products derived from proteins C08H1/00; preparation of glue or gelatine C09H; single cell proteins, enzymes C12N; genetic engineering processes for obtaining peptides C12N15/00; compositions for measuring or testing processes involving enzymes C12Q; investigation or analysis of biological material G01N33/00) ## Abstract Systems and methods used to control tangential flow filtration are provided, including control systems and methods for use with connected systems with upstream processing units, such as chromatography processing units, in fluid communication with a tangential flow filtration processing unit. Also included are control systems and methods for performing continuous concentration using single-pass tangential flow filtration with permeate flow control. ## Claims ### Claim 1 A process control system comprising: a microfiltration unit; a single-pass tangential flow filter having an inlet, a permeate outlet and a retentate outlet; a feed pump with an inlet connected to the microfiltration unit and an outlet connected to the inlet of the filter; a permeate pump with an inlet connected to the permeate outlet of the filter; and a control system coupled to the permeate pump and adapted to control the permeate pump to vary a flow reduction factor, where the flow reduction factor is a ratio of feed flow into the inlet of the single-pass tangential flow filter to retentate flow out of the retentate outlet of the single-pass tangential flow filter, and wherein the control system is adapted to control the permeate pump to vary the flow reduction factor to achieve a target volume reduction factor, where the volume reduction factor is a ratio of cumulative feed volume of the feed flow to cumulative retentate volume of the retentate flow. ### Claim 2 (depends on 1) The process control system according to claim 1, wherein the control system is adapted to control the permeate pump to vary the flow reduction factor in a series of stepwise changes. ### Claim 3 (depends on 2) The process control system according to claim 2, wherein the control system is adapted to control the permeate pump to vary the flow reduction factor in a series of stepwise increases. ### Claim 4 (depends on 1) The process control system according to claim 1, wherein the control system is adapted to control the permeate pump to vary the flow reduction factor continuously. ### Claim 5 (depends on 1) The process control system according to claim 1, wherein the flow reduction factor comprises a first flow reduction factor and the control system is adapted to operate the permeate pump to provide the first flow reduction factor, to subsequently change to a second flow reduction factor that is different than the first flow reduction factor, and to operate the permeate pump to provide the second flow reduction factor. ### Claim 6 (depends on 1) The process control system according to claim 1, wherein the control system comprises at least one processor, the at least one processor programmed to control the permeate pump to vary the flow reduction factor. ### Claim 7 (depends on 6) The process control system according to claim 6, wherein the at least one processor is programmed to control the permeate pump to vary the flow reduction factor to achieve a target volume reduction factor, where the volume reduction factor is a ratio of cumulative feed volume of the feed flow to cumulative retentate volume of the retentate flow. ### Claim 8 (depends on 6) The process control system according to claim 6, wherein the at least one processor is programmed to control the permeate pump to vary the flow reduction factor in a series of stepwise changes. ### Claim 9 (depends on 8) The process control system according to claim 8, wherein the at least one processor is programmed to control the permeate pump to vary the flow reduction factor in a series of stepwise increases. ### Claim 10 (depends on 6) The process control system according to claim 6, wherein the at least one processor is programmed to control the permeate pump to vary the flow reduction factor continuously. ### Claim 11 (depends on 6) The process control system according to claim 6, wherein the flow reduction factor comprises a first flow reduction factor and the at least one processor is programmed to operate the permeate pump to provide the first flow reduction factor, to subsequently change to a second flow reduction factor that is different than the first flow reduction factor, and to operate the permeate pump to provide the second flow reduction factor. ### Claim 12 (depends on 1) The process control system according to claim 1, wherein the control system is coupled to the feed pump and adapted to control the feed pump to provide a constant flow rate. ### Claim 13 (depends on 1) The process control system according to claim 1, comprising a valve disposed between the retentate outlet and a mixing tank, the control system coupled to the valve and adapted to control the valve to provide a backpressure for the filter. ### Claim 14 A process control method comprising: pumping material through a single-pass tangential flow filter having an inlet, a permeate outlet and a retentate outlet; and pumping permeate from the permeate outlet of the filter to vary a flow reduction factor, where the flow reduction factor is a ratio of feed flow into the inlet of the single-pass tangential flow filter to retentate flow out of the retentate outlet of the single-pass tangential flow filter, wherein the flow reduction factor is varied to achieve a target volume reduction factor, where the volume reduction factor is the ratio of cumulative feed volume of the feed flow to cumulative retentate volume of the retentate flow. ### Claim 15 (depends on 14) The process control method according to claim 14, wherein the flow reduction factor is varied in a series of stepwise changes. ### Claim 16 (depends on 15) The process control method according to claim 15, wherein the flow reduction factor is varied in a series of stepwise increases. ### Claim 17 (depends on 14) The process control method according to claim 14, wherein the flow reduction factor is varied continuously. ### Claim 18 (depends on 14) The process control method according to claim 14, wherein flow reduction factor comprises a first flow reduction factor and the pumping of permeate comprises pumping permeate according to the first flow reduction factor, subsequently changing to a second flow reduction factor that is different than the first flow reduction factor, and pumping the permeate according to the second flow reduction factor. ### Claim 19 (depends on 14) The process control method according to claim 14, wherein the pumping material comprises pumping material at a constant feed flow. ### Claim 20 (depends on 14) The process control method according to claim 14, wherein the material comprises cellular material and a protein product. ### Claim 21 (depends on 20) The process control method according to claim 20, wherein the protein product comprises a monoclonal antibody. ### Claim 22 (depends on 14) The process control method according to claim 14, wherein the material at least partly comprises a protein and the method further comprises purifying the protein with an eluate. ### Claim 23 (depends on 22) The process control method according to claim 22, further comprising formulating the protein in a pharmaceutically acceptable excipient.