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Publication Number
US-11766508-B2
Publication Date
2023-09-26
Expiration Date
Abstract
Disclosed is a bioprocessing system comprising apparatus (200) including a centrifugal separation housing (210) having a temperature controllable compartment (215) for removably accepting a separation chamber (50), the apparatus further comprising at least one mixing station (250) for supporting one or more fluid storage vessels (10, 20, 30, 40), the station including a temperature controllable area (252) for increasing or decreasing the temperature of the contents of the or each supported vessel. The system further includes a disposable fluidic arrangement (100) including a centrifugal separation chamber (50) removably mountable within the compartment (215) and having one or more ports (52) allowing fluid ingress into, or egress out of the chamber, via the one or more ports in use, said ports being in fluid communication with one or more of said fluid storage vessels via fluid conduits (12, 22, 32, 42) and via one or more valve arrangement.
Core Innovation
The invention is a compact disposable bioprocessing system that combines a housing with a temperature controllable compartment for removably accepting a separation chamber and at least one station for supporting one or more fluid storage vessels. The at least one station includes a temperature controllable area for increasing or decreasing the temperature therein or of each supported vessel, and a controller and temperature sensing system sense the temperature of both the temperature controllable compartment and the temperature controllable area and operate to heat or cool the temperature controllable area in response to sensed temperature.
The separation chamber is in fluid communication with the one or more fluid storage vessels so that the separation chamber receives a fluid or fluids from the vessels at the same temperature as a cell suspension in the separation chamber. The housing comprises a Peltier element for heating and cooling of the temperature controllable compartment, and the temperature controllable compartment and the temperature controllable area are described as temperature controlled for both the separation compartment and a mixing stage area that supports mixing of fluid storage vessels.
The disposable fluidic arrangement is described as fluidically isolated and includes a separation chamber and fluid storage bags connected via ports through conduits using valve arrangements for selective fluid routing. Temperature is maintained using Peltier elements and infrared temperature sensing, including sensing emitted infrared radiation, while enabling selective multiple bioprocessing functions and reducing thermal shock by introducing reagents or additives at matched or adjusted temperatures, including via the mixing stage.
Claims Coverage
The document provides two independent claims. Inventive features include a bioprocessing system architecture with a temperature-controllable compartment and vessel-support temperature controllable area using controller-driven sensing and Peltier heating/cooling, and a method that temperature-controls further fluids based on the suspension temperature and introduces them at the same temperature; an additional inventive refinement specifies a mixing station for the further fluid(s).
Temperature-controllable compartment accepting a separation chamber
A housing having a temperature controllable compartment for removably accepting a separation chamber, with a separation chamber configured to receive a fluid or fluids from one or more fluid storage vessels at the same temperature as a cell suspension in the separation chamber.
Temperature controllable area for vessels with controller sensing
At least one station for supporting one or more fluid storage vessels, the station including a temperature controllable area for increasing or decreasing the temperature therein or of each supported vessel, with a controller and temperature sensing system sensing the temperature of both the temperature controllable compartment and the temperature controllable area and operating to heat or cool the temperature controllable area in response to sensed temperature.
First and second temperature sensors for compartment and area
A temperature sensing system comprising a first sensor configured to sense the temperature of the temperature controllable compartment and a second sensor configured to sense the temperature of the temperature controllable area, used to drive heating or cooling of the temperature controllable area.
Peltier element for heating and cooling the temperature controllable compartment
A housing comprising a Peltier element for heating and cooling of the temperature controllable compartment configured to accept the separation chamber therein.
Temperature-based control of further fluids introduced at same temperature
A method comprising controlling the temperature of a cell suspension in a separation chamber, introducing a further fluid or fluids into one or more fluid vessels, controlling the temperature of the further fluid or fluids based on the temperature of the suspension, and introducing at least a portion of the further fluid or fluids into the separation chamber at the same temperature as the suspension, with the housing comprising a Peltier element for heating and cooling the temperature controllable compartment.
Mixing station for further fluid(s)
Introducing and mixing the further fluid(s) at a mixing station and introducing at least a portion of the further fluid(s) from the mixing station into the separation chamber at the same temperature as the suspension.
Overall, the independent claim coverage focuses on maintaining temperature relationships between a cell suspension in a separation chamber and fluids stored and subsequently introduced from temperature-controlled storage vessels, using controller-managed temperature sensing and Peltier heating/cooling in a housing configured to accept the separation chamber; a further disclosed refinement specifies introducing further fluid(s) via a mixing station while preserving same-temperature introduction into the separation chamber.
Stated Advantages
Enables selective multiple bioprocessing functions including cell washing, separation and/or concentration, incubation, transduction, density gradient separation, dilution/development, dispensing, and final formulation.
Reduces thermal shock by introducing reagents or additives at matched or adjusted temperatures, including via the mixing stage.
Documented Applications
Selective bioprocessing functions are described, including cell washing; cell separation and/or concentration; cell incubation; cell transduction; density gradient media separation; cell dilution/development; measured cell volume dispensing; and cell final formulation.
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