Process technology for biological product manufacturing and downstream purification
Inventors
Criscione, Jason M. • Ersen, Ali • Linton, John R. • Datwani, Sammy S.
Assignees
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Publication Number
US-11639367-B2
Publication Date
2023-05-02
Expiration Date
Abstract
Provided herein are, inter alia, biological manufacturing and downstream purification processes.
Core Innovation
The invention relates to a process for purifying a biological product by receiving a heterogeneous mixture containing the biological product through an input line and removing impurities by a cell clarification process. The clarification is performed by at least one of a dynamic filtration module, a centrifugation module, a depth filtration module, and a hydrocyclone module, producing a first aqueous solution comprising the biological product. The first aqueous solution is transferred to a second module configured to exchange the first aqueous solution with a second aqueous solution, thereby producing a retentate containing the biological product.
The second module comprises at least one of a tangential flow filtration apparatus, a cross-flow filtration apparatus, and a diafiltration apparatus, and has at least one second inlet and at least one second outlet to permit fluid flow. The retentate is transferred to a third module comprising at least one free-flow electrophoresis apparatus configured to permit continuous fluid flow between a third inlet and a third outlet, and used for separating and recovering the biological product.
The free-flow electrophoresis apparatus includes 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 includes 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. Dependent refinements specify dynamic filtration with a filter membrane extending between a feed reel and a collection reel, substantially smooth contact surfaces, and a vacuum collection system positioned between the feed reel and the collection reel.
Claims Coverage
Two independent claims are provided. Across the independent claims, the coverage centers on cell clarification, exchange to produce a retentate, and continuous free-flow electrophoresis with electrode-channel bubble removal and liquid circuit breaking; one claim also specifies dynamic filtration with a feed reel, a collection reel, and a vacuum collection system.
Module-based purification chain with continuous free-flow electrophoresis
A process for purifying a biological product by receiving a heterogeneous mixture, removing impurities by a cell clarification process using at least one of dynamic filtration, centrifugation, depth filtration, and a hydrocyclone module to produce a first aqueous solution, transferring the first aqueous solution to a second module for exchanging with a second aqueous solution to produce a retentate, transferring the retentate to a third module comprising at least one free-flow electrophoresis apparatus configured for continuous fluid flow, and recovering the biological product.
Dynamic filtration with reel-and-vacuum membrane support arrangement
A process in which cell clarification is performed by a dynamic filtration module where the filter membrane extends between a feed reel and a collection reel with at least one support member having a substantially smooth contact surface, a target region configured to receive the heterogeneous mixture from at least one output head, and a membrane support member with a substantially smooth contact surface in communication with a vacuum collection system positioned between the feed reel and the collection reel.
Electrode-channel wall gap liquid contact with vacuum-driven de-bubbling and liquid circuit breaker
A free-flow electrophoresis apparatus in which electrode channels include an anodic electrode channel and a cathodic electrode channel having liquid contact with a main separation channel via a wall gap, 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.
Across the independent claims, the main inventive coverage is the integrated purification process linking clarification, fluid exchange to generate a retentate, and continuous-flow free-flow electrophoresis. The electrophoresis coverage emphasizes electrode-channel liquid contact via a wall gap, bubble removal via a gas permeable and hydrophobic membrane using a vacuum system to create a bubble-free main separation channel, and inclusion of at least one liquid circuit breaker.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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