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US 11,639,367 B2Granted
Process technology for biological product manufacturing and downstream purification
AssigneeEnquyst Technologies Inc.
InventorsJason M. Criscione, Ali Ersen, John R. Linton, Sammy S. Datwani
Life of this patent
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Abstract
Provided herein are, inter alia, biological manufacturing and downstream purification processes.
Claims21
A process for purifying a biological product, comprising:
- Receiving, via an input line, a heterogeneous mixture containing the biological product;
- Removing impurities from the heterogeneous mixture by a cell clarification process by at least one of a dynamic filtration module, a centrifugation module, depth filtration module, and a hydrocyclone module by feeding the biological product from at least one output in fluid communication with the input line, thereby producing a first aqueous solution comprising the biological product;
- Transferring the first aqueous solution to a second module capable of exchanging the first aqueous solution with a second aqueous solution, thereby producing a retentate containing the biological product, the second module comprising at least one of a tangential flow filtration apparatus, a cross-flow filtration apparatus, and a diafiltration apparatus, wherein the second module has at least one second inlet and at least one second outlet configured to permit fluid flow between the at least one second inlet and the at least one second outlet;
- Transferring the retentate containing the biological product from the at least one outlet of the second module to a third module having at least one inlet for receiving flow from the at least one second outlet of the second module, the third module comprising at least one free-flow electrophoresis apparatus, wherein the third module has at least one second inlet and at least one third outlet and is configured to permit continuous fluid flow between the third inlet and the third outlet;
- wherein the free-flow electrophoresis apparatus comprises electrode channels, including an anodic electrode channel and a cathodic electrode channel, having liquid contact with a main separation channel via a wall gap, the apparatus further having at least one electrode channel de-bubbler comprising at least one gas permeable and hydrophobic membrane configured to remove bubbles by a vacuum system creating a bubble-free main separation channel, and at least one liquid circuit breaker;
- and
- Recovering the biological product.
4 more elements
A process for purifying a biological product, comprising:
- Receiving, via an input line, a heterogeneous mixture containing the biological product;
- Removing impurities from the heterogeneous mixture by a cell clarification process by a dynamic filtration module by feeding the biological product from at least one output in fluid communication with the input line, thereby producing a first aqueous solution comprising the biological product wherein the dynamic filtration apparatus comprises a filter membrane extending between a feed reel and a collection reel with at least one support member having a substantially smooth contact surface, a target region of the filter membrane that is configured to receive the heterogeneous mixture from at least one output head, and a membrane support member with a substantially smooth contact surface that is in communication with a vacuum collection system that is positioned between the feed reel and the collection reel;
- Transferring the first aqueous solution to a second module capable of exchanging the first aqueous solution with a second aqueous solution, thereby producing a retentate containing the biological product, the second module comprising at least one of a tangential flow filtration apparatus, a cross-flow filtration apparatus, and a diafiltration apparatus, wherein the second module has at least one second inlet and at least one second outlet configured to permit fluid flow between the at least one second inlet and the at least one second outlet;
- Transferring the retentate containing the biological product from the at least one outlet of the second module to a third module having at least one inlet for receiving flow from the at least one second outlet of the second module, the third module comprising at least one free-flow electrophoresis apparatus, wherein the third module has at least one second inlet and at least one third outlet and is configured to permit continuous fluid flow between the third inlet and the third outlet;
- and
- Recovering the biological product.
3 more elements
Dependencies are inferred from the claim text.